Approval Trends of Recombinant DNA (r-DNA) Therapeutics in India: A Five- Year Review
Abstract
Introduction: Recombinant DNA (r-DNA) technology has revolutionized modern therapeutics, enabling the large-scale production of safe, effective, and targeted biologics. India has witnessed a growing adoption of r-DNA-based therapies in diverse disease areas over the past five years. This review systematically analyzes the approval trends of r-DNA therapeutics in India between 2020 and 2024, highlights regulatory frameworks, therapeutic areas, and discusses the associated market dynamics and challenges. Approval data were obtained from the Central Drugs Standard Control Organization (CDSCO) and supplemented with information from published literature, drug databases, and industry reports. Therapeutics were categorized based on indication, origin (indigenous/imported), and product type. A total of 111 r-DNA therapeutics was approved over the five-year period, with a significant surge in 2023. Oncology constituted the leading therapeutic area (38% of total approvals), followed by diabetes, hemophilia, and osteoporosis. The majority of approvals were monoclonal antibodies and recombinant proteins. Despite the progress, a substantial portion of the products remain imported, highlighting gaps in local manufacturing.
Conclusion: India is emerging as a significant player in r-DNA therapeutics. However, regulatory harmonization, indigenous development, cost containment, and infrastructure strengthening are essential to realize the full potential of r-DNA technology in improving public health outcomes.
Keywords:
Biologics, Recombinant DNA (r-DNA), Approval Trends, CDSCO, US FDA, EMA, Biotechnology, Cancer, Haematological disorder, Diabetes, Osteoporosis
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References
1. Walsh G. Biopharmaceutical benchmarks 2018. Nature Biotechnology [Internet]. 2018 Dec 06 [cited 2025 May 3];36(12):1136-45. Available from:
https://doi.org/10.1038/nbt.430
2. Leader B, Baca QJ, Golan DE. Protein therapeutics: a summary and pharmacological classification. Nature Reviews Drug Discovery [Internet]. 2008 Jan [cited 2025 May 3];7(1):21–39. Available from:
https://doi.org/10.1038/nrd2399
3. Hopkins AL, Groom CR. The druggable genome. Nature Reviews Drug Discovery [Internet]. 2002 Sep [cited 2025 May 3];1(9):727–30. Available from:
https://doi.org/10.1038/nrd892
4. Santos R, Ursu O, Gaulton A, Bento AP, Donadi RS, Bologa CG, et al. A comprehensive map of molecular drug targets. Nature Reviews Drug Discovery [Internet]. 2017 Jan 02 [cited 2025 May 3];16(1):19–34. Available from:
https://doi.org/10.1038/nrd.2016.230
5. Zogg H, Singh R, Ro S. Current Advances in RNA Therapeutics for Human Diseases. International Journal of Molecular Sciences [Internet]. 2022 Mar 1[cited 2025 May 3];23(5).
Available from: https://doi.org/10.3390/ijms23052736
6. Dowdy SF. Overcoming cellular barriers for RNA therapeutics. Nature Biotechnology [Internet]. 2017 Mar 27 [cited 2025 May 3];35(3):222–9. Available from:
https://doi.org/10.1038/nbt.3802
7. Sahay G, Alakhova DY, Kabanov A V. Endocytosis of nanomedicines. The Journal of Controlled Release [Internet]. 2010 Aug 03 [cited 2025 May 3];145(3):182–95.
Available from:
https://doi.org/10.1016/j.jconrel.2010.01.036
8. Department of Biotechnology, Central Drugs Standard Control Organization. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India [Internet]. New Delhi: CDSCO; 2025 [cited 2025 May 3]. Available from:
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Bio-Tech/SIMILAR-BIOLOGICS-Guidelines.pdf
9. Natarajan J, Janani.R. A review on Regulatory guidelines for biologics in India. Journal of Pharmaceutical Sciences and Research [Internet]. 2019 [cited 2025 May 3];11(11):3651-3654. Available from:
https://www.jpsr.pharmainfo.in › jpsr11111919
10. Ken-ichi Izutsu. Production of Recombinant Proteins: Techniques, Challenges and Future Directions. Pharmaceutical Bioprocessing. 2024 Oct 28;12(5):232–3. doi: 10.37532/2048-9145
11. ICH. The Common Technical Document [Internet]. US: ICH; 2025 [cited 2025 May 3]. Available from:
https://www.ich.org/products/ctd.html
12. Meher B, Balan S, Mohanty R, Jena M, Das S. Biosimilars in India; current status and future perspectives. Journal of Pharmacy and Bioallied Sciences [Internet]. 2019[cited 2025 May 3];11(1):12. Available from:
https://doi.org/10.4103/jpbs.JPBS_167_18
13. Uppal A, Chakrabarti R, Chirmule N, Rathore A, Atouf F. Biopharmaceutical Industry Capability Building in India: Report from a Symposium. Journal of Pharmaceutical Innovation [Internet]. 2022 Dec 26 [cited 2025 May 3];17(4):1555–62. Available from:
https://doi.org/10.1007/s12247-021-09596-9
14. Rathore AS, Bhargava A. Regulatory considerations in biosimilars: Asia pacific regions. Preparative Biochemistry & Biotechnology [Internet]. 2021 Jan 02 [cited 2025 May 3];51(1):1–8. Available from:
https://doi.org/10.1080/10826068.2020.1815061
15. India Biosimilars Market Analysis [Internet]. India: Insights10; 2023 [cited 2025 May 3]. Available from:
https://www.insights10.com/report/india-biosimilars-market-analysis/
16. IMARC Group. India Biologics Market Size, Share, Trends and Forecast by Source, Product, Disease, Manufacturing, and Region, 2025–2033 [Internet]. India: IMARC Group; 2024 [cited 2025 May 3]. Available from:
https://www.imarcgroup.com/india-biologics-market
17. Monga A, Gagan, Jamwal P, Sharma S, Kaur A. Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications. American Association of Pharmaceutical Scientists [Internet]. 2025 Jan 27;26(1):46. Available from:
https://doi.org/10.1208/s12249-025-03038-2
18. Bhardwaj R, Manchikanti P, Raju KD. Competition Regulation and Recombinant Drugs in India. Journal of Commercial Biotechnology [Internet]. 2013 Oct 03 [cited 2025 May 3];19(4). Available from:
http://dx.doi.org/10.5912/jcb609
19. Kanase S, Gavhane Y, Khandekar A, Gurav A, Yadav AV. Biosimilar: An Overview. International Journal of Pharmceutical Sciences and Research [Internet]. 2013 [cited 2025 May 03];4(6):2132–44. Available from:
http://dx.doi.org/10.13040/IJPSR.0975-8232.4(6).2132-44
20. Mazumdar-Shaw K. Leveraging affordable innovation to tackle India’s healthcare challenge. IIMB Management Review [Internet]. 2018 Mar [cited 2025 May 03];30(1):37–50. Available from:
http://dx.doi.org/10.1016/j.iimb.2017.11.003
21. Chhabra H, Mouslim MC, Kashiramka S, Rathore AS. Dynamics of biosimilar uptake in emerging markets. Expert Opinion on Biological Therapy [Internet]. 2022 Jun 03 [cited 2025 May 3];22(6):679–88. Available from:
https://doi.org/10.1080/14712598.2022.2076557
22. Panda S, Singh PK, Mishra S, Mitra S, Pattnaik P, Adhikary S Das. Indian Biosimilars and Vaccines at Crossroads–Replicating the Success of Pharmagenerics. Vaccines [Internet]. 2023 Jan 2 [cited 2025 May 03];11(1):110. Available from: https://doi.org/10.3390/vaccines11010110
23. Rozas P, Kessi-Pérez EI, Martínez C. Genetically modified organisms: adapting regulatory frameworks for evolving genome editing technologies. Biological Research [Internet].2022 Oct 20 [cited 2025 May 03];55(1):31. Available from:
https://doi.org/10.1186/s40659-022-00399-x
24. Sprink T, Wilhelm R. Genome Editing in Biotech Regulations Worldwide. In: Ricroch A, Eriksson D, Miladinović D, Sweet J, Van Laere K, Woźniak-Gientka E, editors. A Roadmap for Plant Genome Editing. Cham: Springer Nature Switzerland; 2024. p. 425–435. Available from:
https://doi.org/10.1007/978-3-031-46150-7_25
25. Prakash UG. Biosimilars Pharmaceutical Market in India: Current Status, Challenges and Future Perspective. Bioscience, Biotechnology, and Biochemistry [Internet]. 2021 Mar 30[cited 2025 May 03];14(1):47–54. Available from: https://doi.org/10.4103/jpbs.JPBS_167_18
26. Central Drugs Standard Control Organization (CDSCO). r-DNA [Internet]. India: CDSCO;2025 [cited 2025 May 3]. Available from:
https://cdsco.gov.in/opencms/opencms/en/biologicals/r-DNA
27. Anand U, Dey A, Chandel AKS, Sanyal R, Mishra A, Pandey DK, et al. Cancer chemotherapy and beyond: Current status, drug candidates, associated risks and progress in targeted therapeutics. Genes & Diseases [Internet]. 2023 Jul [cited 2025 May 03];10(4):1367–401.
Available from:
https://doi.org/10.1016/j.gendis.2022.02.007
28. Maiorano BA, Catalano M, Maiello E, Roviello G. Enfortumab vedotin in metastatic urothelial carcinoma: the solution Eventually. Frontiers in Oncology [Internet]. 2023 Sep 13[cited 2025 May 03];13. Available from:
https://doi.org/10.3389/fonc.2023.1254906
29. Guo L, Zhang H, Chen B. Nivolumab as Programmed Death-1 (PD-1) Inhibitor for Targeted Immunotherapy in Tumor. Journal of Cancer [Internet]. 2017 Feb 10 [cited 2025 May 03];8(3):410. Available from:
https://doi.org/10.7150/jca.17144
30. Schwartz RS, Abildgaard CF, Aledort LM, Arkin S, Bloom AL, Brackmann HH, et al. Human recombinant DNA-derived antihemophilic factor (factor VIII) in the treatment of hemophilia A. recombinant Factor VIII Study Group. The New England journal of medicine [Internet]. 1990 Dec 27 [cited 2025 May 03];323(26):1800–5. Available from:
https://doi.org/10.1056/nejm199012273232604
31. Portolés J, Martín L, Broseta JJ, Cases A. Anemia in Chronic Kidney Disease: From Pathophysiology and Current Treatments, to Future Agents. Frontiers in Medicine [Internet]. 2021 Mar 26 [cited 2025 May 03];8:642296. Available from: https://doi.org/10.3389/fmed.2021.642296
32. Hasserjian RP, Germing U, Malcovati L. Diagnosis and classification of myelodysplastic syndromes. Blood: The Journal of the American Society of Hematology [Internet]. 2023 Dec 28[cited 2025 May 03];142(26):2247–57.
Available from: https://doi.org/10.1182/blood.2023020078
33. Amjad F, Fatima T, Fayyaz T, Khan M, Qadeer M. Novel genetic therapeutic approaches for modulating the severity of & beta thalassemia. Biomedical Reports [Internet]. 2020 Sep 02 [cited 2025 May 03];13(5):1–1. Available from:
https://doi.org/10.3892/br.2020.1355
34. Vajo Z, Fawcett J, Duckworth WC. Recombinant DNA technology in the treatment of diabetes: insulin analogs. Endocrine reviews [Internet]. 2001 Oct [cited 2025 May 03];22(5):706–17. Available from:
https://doi.org/10.1210/edrv.22.5.0442
35. Tsurayya G, Nazhifah CA, Pirwanja MR, Zulfa PO, Tatroman MRR, Fakri F. Once-Weekly Somapacitan as an Alternative Management of Growth Hormone Deficiency in Prepubertal Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trial. Children [Internet]. 2024 Feb 9[cited 2025 May 03];11(2):227.
Available from: https://doi.org/10.3390/children11020227
36. Pleș H, Florian IA, Timis TL, Covache-Busuioc RA, Glavan LA, Dumitrascu DI, et al. Migraine: Advances in the Pathogenesis and Treatment. Neurology International [Internet]. 2023 Aug 31[cited 2025 May 03];15(3):1052–105. Available from:
https://doi.org/10.3390/neurolint15030067
37. Yadav S, Schanz R, Maheshwari A, Khan MS, Slark J, de Silva R. Bio-Repository of DNA in stroke (BRAINS): a study protocol. BMC medical genetics [Internet]. 2011 Mar 02 [cited 2025 May 03]; 12:34. Available from:
https://doi.org/10.1186/1471-2350-12-34
38. Voigt I, Inojosa H, Dillenseger A, Haase R, Akgün K, Ziemssen T. Digital Twins for Multiple Sclerosis. Frontiers in Immunology [Internet]. 2021 May 03 [cited 2025 May 03]; 12:669811. Available from:
https://doi.org/10.3389/fimmu.2021.669811
39. Wei W, Ma D, Li L, Zhang L. Progress in the Application of Drugs for Treatment of Multiple Sclerosis. Frontiers in Pharmacology [Internet]. 2021 Jul 13 [cited 2025 May 03];12: 724718. Available from:
https://doi.org/10.3389/fphar.2021.724718
40. Pucci E, Giuliani G, Solari A, Simi S, Minozzi S, di Pietrantonj C, et al. Natalizumab for relapsing remitting multiple sclerosis. The Cochrane database of systematic reviews [Internet]. 2011 Oct 05 [cited 2025 May 03]; (10):CD007621. Available from:
https://doi.org/10.1002/14651858.cd007621.pub2
41. Talanki Manjunatha R, Habib S, Sangaraju SL, Yepez D, Grandes XA. Multiple Sclerosis: Therapeutic Strategies on the Horizon. Cureus Journal of Medical Science [Internet]. 2022 May [cited 2025 May 03];14(5):24895.
Available from: https://doi.org/10.7759/cureus.24895
42. Farrugia M, Baron B. The role of TNF-α in rheumatoid arthritis: a focus on regulatory T cells. Journal of clinical and translational research [Internet]. 2016 Nov 10 [cited 2025 May 03];2(3):84–90. Available from:
http://dx.doi.org/10.18053/jctres.02.201603.005
43. Zhu Y, Zhu L, Wang X, Jin H.RNA-based therapeutics: an overview and prospectus. Cell death and disease [Internet]. 2022 Jul 23[cited 2025 May 03];13(7):644. Available from:
https://doi.org/10.1038/s41419-022-05075-2
44. Hoffmann B, Mayatepek E. Fabry disease-often seen, rarely diagnosed. Deutsches Arzteblatt international [Internet]. 2009 Jun [cited 2025 May 03];106(26):440–7.
Available from: https://doi.org/10.3238/arztebl.2009.0440
45. Segal JP, LeBlanc JF, Hart AL. Ulcerative colitis. Lancet [Internet]. 2023 [cited 2025 May 03];402(10376):1–2. Available from:
https://doi.org/10.1016/s0140-6736(23)00966-2
46. Rudrapatna VA, Velayos F. Biosimilars for the Treatment of Inflammatory Bowel Disease. Practical gastroenterology [Internet]. 2019 Apr [cited 2025 May 03];43(4):84–91. Available from:
https://pmc.ncbi.nlm.nih.gov/articles/PMC6703165/
47. Veauthier B, Hornecker JR. Crohn’s Disease: Diagnosis and Management. American family physician [Internet]. 2018 Dec 1[cited 2025 May 03];98(11):661–9. Available from:
https://pubmed.ncbi.nlm.nih.gov/30485038/
48. Yeshi K, Ruscher R, Hunter L, Daly NL, Loukas A, Wangchuk P. Revisiting Inflammatory Bowel Disease: Pathology, Treatments, Challenges and Emerging Therapeutics Including Drug Leads from Natural Products. Journal of clinical medicine [Internet]. 2020 Apr 28 [cited 2025 May 03];9(5):1273. Available from:
https://doi.org/10.3390/jcm9051273
49. Jussila A, Virta LJ, Pukkala E, Färkkilä MA. Mortality and causes of death in patients with inflammatory bowel disease: a nationwide register study in Finland. Journal of Crohn’s & colitis [Internet]. 2014 Sep [cited 2025 May 03];8(9):1088–96. Available from:
https://doi.org/10.1016/j.crohns.2014.02.015
50. Llerena JC, Horovitz DM, Marie SKN, Porta G, Giugliani R, Rojas MVM, et al. The Brazilian consensus on the management of Pompe disease. The Journal of pediatrics [Internet]. 2009 Oct [cited 2025 May 03];155(4 Suppl):S47-56. Available from:
https://doi.org/10.1016/j.jpeds.2009.07.006
51. Dornelles AD, Junges APP, Krug B, Gonçalves C, de Oliveira Junior HA, Schwartz IVD. Efficacy and safety of enzyme replacement therapy with alglucosidase alfa for the treatment of patients with infantile-onset Pompe disease: a systematic review and metanalysis. Frontiers in Pediatrics [Internet]. 2024 Feb 15 [cited 2025 May 03]; 12:1310317.
Available from: https://doi.org/10.3389/fped.2024.1310317
52. Taverna S, Cammarata G, Colomba P, Sciarrino S, Zizzo C, Francofonte D, et al. Pompe di sease: pathogenesis, molecular genetics and diagnosis. Aging [Internet]. 2020 Aug 03[cited 2025 May 03];12(15):15856–74.
Available from: https://doi.org/10.18632/aging.103794
53. Moravej H, Karamizadeh Z, Paran M. The Outcome of Infantile Onset Pompe Disease in South of Iran. Iranian journal of pediatrics [Internet].2016 Feb [cited 2025 May 03];26(1):4473. Available from:
https://doi.org/10.5812/ijp.4473
54. Peters H, Ellaway C, Nicholls K, Reardon K, Szer J. Treatable lysosomal storage diseases in the advent of disease-specific therapy. Internal medicine journal [Internet].2020 Nov[cited 2025 May 03];50 (Suppl 4):5–27.
Available from: https://doi.org/10.1111/imj.15100
55. D’Avanzo F, Rigon L, Zanetti A, Tomanin R. Mucopolysaccharidosis Type II: One Hundred Years of Research, Diagnosis, and Treatment. International journal of molecular sciences [Internet]. 2020 Feb 13 [cited 2025 May 03];21(4):1258.
Available from: https://doi.org/10.3390/ijms21041258
56. Zapolnik P, Pyrkosz A. Gene Therapy for Mucopolysaccharidosis Type II-A Review of the Current Possibilities. International journal of molecular sciences [Internet]. 2021 May 23[cited 2025 May 03]; 22(11):5490.
Available from: https://doi.org/10.3390/ijms22115490
57. Rake JP, Visser G, Labrune P, Leonard JV, Ullrich K, Smit GPA. Guidelines for management of glycogen storage disease type I – European Study on Glycogen Storage Disease Type I (ESGSD I). European Journal of Pediatrics [Internet]. 2002 Nov [cited 2025 May 03];161 (Suppl 1): 112-9. Available from:
https://doi.org/10.1007/s00431-002-1016-7
58. Pinto C, Sousa D, Ghilas V, Dardis A, Scarpa M, Macedo MF. Acid Sphingomyelinase Deficiency: A Clinical and Immunological Perspective. International journal of molecular sciences [Internet]. 2021 Nov 28 [cited 2025 May 03]; 22(23):12870. Available from:
https://doi.org/10.3390/ijms222312870
59. Sözen T, Özışık L, Başaran NÇ. An overview and management of osteoporosis. European journal of rheumatology [Internet]. 2017 Mar [cited 2025 May 03];4(1):46–56. Available from:
https://doi.org/10.5152/eurjrheum.2016.048
60. Zeghoud S, ben Amor I, Alnazza Alhamad A, Darwish L, Hemmami H. Osteoporosis therapy using nanoparticles: a review. Annals of medicine and surgery [Internet]. 2012 Jan [cited 2025 May 3];86(1):284–91. Available from:
https://doi.org/10.1097/ms9.0000000000001467
61. Chen LR, Ko NY, Chen KH. Medical Treatment for Osteoporosis: From Molecular to Clinical Opinions. International journal of molecular sciences [Internet]. 2019 May 6 [cited 2025 May 03]; 20(9):2213. Available from:
https://doi.org/10.3390/ijms20092213
62. Guimaraes TAC de, Georgiou M, Bainbridge JWB, Michaelides M. Gene therapy for neovascularage-related macular degeneration: rationale, clinical trials and future directions. The British journal of ophthalmology [Internet]. 2021 Feb [cited 2025 May 03];105(2):151–7. Available from:
https://doi.org/10.1136/bjophthalmol-2020-316195
63. Ferris FL, Wilkinson CP, Bird A, Chakravarthy U, Chew E, Csaky K, et al. Clinical classific ation of age-related macular degeneration. Ophthalmology [Internet]. 2013 Apr [cited 2025 May 03];120(4):844–51. Available from:
https://doi.org/10.1016/j.ophtha.2012.10.036
64. Leung MYM, Pollack LM, Colditz GA, Chang SH. Life years lost and lifetime health care expenditures associated with diabetes in the U.S., National Health Interview Survey, 1997-2000. Diabetes care [Internet]. 2015 Mar [cited 2025 May 03];38(3):460–8. Available from:
https://doi.org/10.2337/dc14-1453
65. Cerdá C, Camps J. Oxidative stress and DNA damage in obesity-related tumorigenesis. In: Camps J, editor. Oxidative stress and inflammation in non-communicable diseases: molecular mechanisms and perspectives in therapeutics. Cham: Springer; 2014. p. 21–39.
Doi:10.1007/978-3-319-07320-0_2.
66. Włodarczyk M, Nowicka G. Obesity, DNA Damage, and Development of Obesity-Related Diseases. International journal of molecular sciences [Internet]. 2019 Mar 06 [cited 2025 May 03]; 20(5):1146.
Available from: https://doi.org/10.3390/ijms20051146
67. Caserta MT, O’Leary ST, Munoz FM, Ralston SL, O’Leary ST, Campbell JD, et al. Palivizu mab Prophylaxis in Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection. Pediatrics [Internet]. 2023 Jul 01 [cited 2025 May 03];152 (1): e2023061803.
Available from: https://doi.org/10.1542/peds.2023-061803
68. Pelaia C, Crimi C, Vatrella A, Tinello C, Terracciano R, Pelaia G. Molecular Targets for Biological Therapies of Severe Asthma. Frontiers in immunology [Internet]. 2020; [cited 2025 May 03] 11:603312.
Available from:
https://doi.org/10.3389/fimmu.2020.603312
69. Pelaia C, Vatrella A, Bruni A, Terracciano R, Pelaia G. Benralizumab in the treatment of severe asthma: design, development and potential place in therapy. Drug design, development and therapy [Internet]. 2018 [cited 2025 May 03]; 12:619–28.
Available from: https://doi.org/10.2147/dddt.s155307
70. Lowes MA, Suárez-Fariñas M, Krueger JG. Immunology of psoriasis. Annual review of immunology [Internet]. 2014 [cited 2025 May 03]; 32:227–55.
Available from: https://doi.org/10.1146/annurev-immunol-032713-120225
71. di Cesare A, di Meglio P, Nestle FO. The IL-23/Th17 axis in the immunopathogenesis of psoriasis. The Journal of investigative dermatology [Internet]. 2009 Jun [cited 2025 May 03];129(6):1339–50.
Available from: https://doi.org/10.1038/jid.2009.59
72. Pavli P, Triantafyllidou O, Kapantais E, Vlahos NF, Valsamakis G. Infertility Improvement after Medical Weight Loss in Women and Men: A Review of the Literature. International journal of molecular sciences [Internet]. 2024 Feb 05[cited 2025 May 03];25(3).
Available from: https://doi.org/10.3390/ijms25031909
73. Fu Q, Hu L, Shen T, Yang R, Jiang L. Recent Advances in Gene Therapy for Familial Hypercholesterolemia: An Update Review. Journal of clinical medicine [Internet]. 2022 Nov 16 [cited 2025 May 03]; 11(22):6773.
Available from: https://doi.org/10.3390/jcm11226773
74. Khan S, Ullah MW, Siddique R, Nabi G, Manan S, Yousaf M, et al. Role of r-DNA Technology to Improve Life. International journal of genomics [Internet].2016[cited 2025 May 03]; 2016:2405954. Available from:
https://doi.org/10.1155/2016/2405954
75. Chheda U, Pradeepan S, Esposito E, Strezsak S, Fernandez-Delgado O, Kranz J. Factors Affecting Stability of RNA – Temperature, Length, Concentration, pH, and Buffering Species. Journal of Pharmaceutical Sciences [Internet]. 2024 Feb [cited 2025 May 03];113(2):377–85.
Available from: https://doi.org/10.1016/j.xphs.2023.11.023
76. Sanjeev S, Sharma S, Gupta R. Regulatory aspects for biologic product licensing in India. International Journal of Drug Regulatory Affairs [Internet]. 2019 [cited 2025 May 03];7(1):1-5. Available from:
https://doi.org/10.22270/ijdra.v7i1.287
77. Pemmasani SK, Raman R, Mohapatra R, Vidyasagar M, Acharya A. A Review on the Challenges in Indian Genomics Research for Variant Identification and Interpretation. Frontiers in genetics [Internet]. 2020 [cited 2025 May 03]; 11:753. Available from:
https://doi.org/10.3389/fgene.2020.00753
78. Ghagne S, Nerli R, Baligar P, Hiremath M. Status and Application of Recombinant DNA Therapeutic Products Used in Clinical Practices: An Indian Scenario. Social Science Research Network Electronic Journal [Internet]. 2016 [cited 2025 May 03] 2016: 2783940.
Available from: https://dx.doi.org/10.2139/ssrn.2783940
79. Uppal A, Chakrabarti R, Chirmule N, Rathore A, Atouf F. Biopharmaceutical Industry Capability Building in India: Report from a Symposium. Journal of Pharmaceutical Innovation [Internet]. 2022 [cited 2025 May 03]; 17(4):1555–62. Available from:
https://doi.org/10.1007/s12247-021-09596-9
80. Avhad VR, Patil SB. A Comparison of US, Europe, Japan and India Biosimilar Regulation. International Journal of Drug Regulatory Affairs [Internet]. 2025 Mar 15 [cited 2025 May 03];13(1):34-9. Available from:
https://www.ijdra.com/index.php/journal /article/view/745
https://doi.org/10.1038/nbt.430
2. Leader B, Baca QJ, Golan DE. Protein therapeutics: a summary and pharmacological classification. Nature Reviews Drug Discovery [Internet]. 2008 Jan [cited 2025 May 3];7(1):21–39. Available from:
https://doi.org/10.1038/nrd2399
3. Hopkins AL, Groom CR. The druggable genome. Nature Reviews Drug Discovery [Internet]. 2002 Sep [cited 2025 May 3];1(9):727–30. Available from:
https://doi.org/10.1038/nrd892
4. Santos R, Ursu O, Gaulton A, Bento AP, Donadi RS, Bologa CG, et al. A comprehensive map of molecular drug targets. Nature Reviews Drug Discovery [Internet]. 2017 Jan 02 [cited 2025 May 3];16(1):19–34. Available from:
https://doi.org/10.1038/nrd.2016.230
5. Zogg H, Singh R, Ro S. Current Advances in RNA Therapeutics for Human Diseases. International Journal of Molecular Sciences [Internet]. 2022 Mar 1[cited 2025 May 3];23(5).
Available from: https://doi.org/10.3390/ijms23052736
6. Dowdy SF. Overcoming cellular barriers for RNA therapeutics. Nature Biotechnology [Internet]. 2017 Mar 27 [cited 2025 May 3];35(3):222–9. Available from:
https://doi.org/10.1038/nbt.3802
7. Sahay G, Alakhova DY, Kabanov A V. Endocytosis of nanomedicines. The Journal of Controlled Release [Internet]. 2010 Aug 03 [cited 2025 May 3];145(3):182–95.
Available from:
https://doi.org/10.1016/j.jconrel.2010.01.036
8. Department of Biotechnology, Central Drugs Standard Control Organization. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India [Internet]. New Delhi: CDSCO; 2025 [cited 2025 May 3]. Available from:
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Bio-Tech/SIMILAR-BIOLOGICS-Guidelines.pdf
9. Natarajan J, Janani.R. A review on Regulatory guidelines for biologics in India. Journal of Pharmaceutical Sciences and Research [Internet]. 2019 [cited 2025 May 3];11(11):3651-3654. Available from:
https://www.jpsr.pharmainfo.in › jpsr11111919
10. Ken-ichi Izutsu. Production of Recombinant Proteins: Techniques, Challenges and Future Directions. Pharmaceutical Bioprocessing. 2024 Oct 28;12(5):232–3. doi: 10.37532/2048-9145
11. ICH. The Common Technical Document [Internet]. US: ICH; 2025 [cited 2025 May 3]. Available from:
https://www.ich.org/products/ctd.html
12. Meher B, Balan S, Mohanty R, Jena M, Das S. Biosimilars in India; current status and future perspectives. Journal of Pharmacy and Bioallied Sciences [Internet]. 2019[cited 2025 May 3];11(1):12. Available from:
https://doi.org/10.4103/jpbs.JPBS_167_18
13. Uppal A, Chakrabarti R, Chirmule N, Rathore A, Atouf F. Biopharmaceutical Industry Capability Building in India: Report from a Symposium. Journal of Pharmaceutical Innovation [Internet]. 2022 Dec 26 [cited 2025 May 3];17(4):1555–62. Available from:
https://doi.org/10.1007/s12247-021-09596-9
14. Rathore AS, Bhargava A. Regulatory considerations in biosimilars: Asia pacific regions. Preparative Biochemistry & Biotechnology [Internet]. 2021 Jan 02 [cited 2025 May 3];51(1):1–8. Available from:
https://doi.org/10.1080/10826068.2020.1815061
15. India Biosimilars Market Analysis [Internet]. India: Insights10; 2023 [cited 2025 May 3]. Available from:
https://www.insights10.com/report/india-biosimilars-market-analysis/
16. IMARC Group. India Biologics Market Size, Share, Trends and Forecast by Source, Product, Disease, Manufacturing, and Region, 2025–2033 [Internet]. India: IMARC Group; 2024 [cited 2025 May 3]. Available from:
https://www.imarcgroup.com/india-biologics-market
17. Monga A, Gagan, Jamwal P, Sharma S, Kaur A. Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications. American Association of Pharmaceutical Scientists [Internet]. 2025 Jan 27;26(1):46. Available from:
https://doi.org/10.1208/s12249-025-03038-2
18. Bhardwaj R, Manchikanti P, Raju KD. Competition Regulation and Recombinant Drugs in India. Journal of Commercial Biotechnology [Internet]. 2013 Oct 03 [cited 2025 May 3];19(4). Available from:
http://dx.doi.org/10.5912/jcb609
19. Kanase S, Gavhane Y, Khandekar A, Gurav A, Yadav AV. Biosimilar: An Overview. International Journal of Pharmceutical Sciences and Research [Internet]. 2013 [cited 2025 May 03];4(6):2132–44. Available from:
http://dx.doi.org/10.13040/IJPSR.0975-8232.4(6).2132-44
20. Mazumdar-Shaw K. Leveraging affordable innovation to tackle India’s healthcare challenge. IIMB Management Review [Internet]. 2018 Mar [cited 2025 May 03];30(1):37–50. Available from:
http://dx.doi.org/10.1016/j.iimb.2017.11.003
21. Chhabra H, Mouslim MC, Kashiramka S, Rathore AS. Dynamics of biosimilar uptake in emerging markets. Expert Opinion on Biological Therapy [Internet]. 2022 Jun 03 [cited 2025 May 3];22(6):679–88. Available from:
https://doi.org/10.1080/14712598.2022.2076557
22. Panda S, Singh PK, Mishra S, Mitra S, Pattnaik P, Adhikary S Das. Indian Biosimilars and Vaccines at Crossroads–Replicating the Success of Pharmagenerics. Vaccines [Internet]. 2023 Jan 2 [cited 2025 May 03];11(1):110. Available from: https://doi.org/10.3390/vaccines11010110
23. Rozas P, Kessi-Pérez EI, Martínez C. Genetically modified organisms: adapting regulatory frameworks for evolving genome editing technologies. Biological Research [Internet].2022 Oct 20 [cited 2025 May 03];55(1):31. Available from:
https://doi.org/10.1186/s40659-022-00399-x
24. Sprink T, Wilhelm R. Genome Editing in Biotech Regulations Worldwide. In: Ricroch A, Eriksson D, Miladinović D, Sweet J, Van Laere K, Woźniak-Gientka E, editors. A Roadmap for Plant Genome Editing. Cham: Springer Nature Switzerland; 2024. p. 425–435. Available from:
https://doi.org/10.1007/978-3-031-46150-7_25
25. Prakash UG. Biosimilars Pharmaceutical Market in India: Current Status, Challenges and Future Perspective. Bioscience, Biotechnology, and Biochemistry [Internet]. 2021 Mar 30[cited 2025 May 03];14(1):47–54. Available from: https://doi.org/10.4103/jpbs.JPBS_167_18
26. Central Drugs Standard Control Organization (CDSCO). r-DNA [Internet]. India: CDSCO;2025 [cited 2025 May 3]. Available from:
https://cdsco.gov.in/opencms/opencms/en/biologicals/r-DNA
27. Anand U, Dey A, Chandel AKS, Sanyal R, Mishra A, Pandey DK, et al. Cancer chemotherapy and beyond: Current status, drug candidates, associated risks and progress in targeted therapeutics. Genes & Diseases [Internet]. 2023 Jul [cited 2025 May 03];10(4):1367–401.
Available from:
https://doi.org/10.1016/j.gendis.2022.02.007
28. Maiorano BA, Catalano M, Maiello E, Roviello G. Enfortumab vedotin in metastatic urothelial carcinoma: the solution Eventually. Frontiers in Oncology [Internet]. 2023 Sep 13[cited 2025 May 03];13. Available from:
https://doi.org/10.3389/fonc.2023.1254906
29. Guo L, Zhang H, Chen B. Nivolumab as Programmed Death-1 (PD-1) Inhibitor for Targeted Immunotherapy in Tumor. Journal of Cancer [Internet]. 2017 Feb 10 [cited 2025 May 03];8(3):410. Available from:
https://doi.org/10.7150/jca.17144
30. Schwartz RS, Abildgaard CF, Aledort LM, Arkin S, Bloom AL, Brackmann HH, et al. Human recombinant DNA-derived antihemophilic factor (factor VIII) in the treatment of hemophilia A. recombinant Factor VIII Study Group. The New England journal of medicine [Internet]. 1990 Dec 27 [cited 2025 May 03];323(26):1800–5. Available from:
https://doi.org/10.1056/nejm199012273232604
31. Portolés J, Martín L, Broseta JJ, Cases A. Anemia in Chronic Kidney Disease: From Pathophysiology and Current Treatments, to Future Agents. Frontiers in Medicine [Internet]. 2021 Mar 26 [cited 2025 May 03];8:642296. Available from: https://doi.org/10.3389/fmed.2021.642296
32. Hasserjian RP, Germing U, Malcovati L. Diagnosis and classification of myelodysplastic syndromes. Blood: The Journal of the American Society of Hematology [Internet]. 2023 Dec 28[cited 2025 May 03];142(26):2247–57.
Available from: https://doi.org/10.1182/blood.2023020078
33. Amjad F, Fatima T, Fayyaz T, Khan M, Qadeer M. Novel genetic therapeutic approaches for modulating the severity of & beta thalassemia. Biomedical Reports [Internet]. 2020 Sep 02 [cited 2025 May 03];13(5):1–1. Available from:
https://doi.org/10.3892/br.2020.1355
34. Vajo Z, Fawcett J, Duckworth WC. Recombinant DNA technology in the treatment of diabetes: insulin analogs. Endocrine reviews [Internet]. 2001 Oct [cited 2025 May 03];22(5):706–17. Available from:
https://doi.org/10.1210/edrv.22.5.0442
35. Tsurayya G, Nazhifah CA, Pirwanja MR, Zulfa PO, Tatroman MRR, Fakri F. Once-Weekly Somapacitan as an Alternative Management of Growth Hormone Deficiency in Prepubertal Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trial. Children [Internet]. 2024 Feb 9[cited 2025 May 03];11(2):227.
Available from: https://doi.org/10.3390/children11020227
36. Pleș H, Florian IA, Timis TL, Covache-Busuioc RA, Glavan LA, Dumitrascu DI, et al. Migraine: Advances in the Pathogenesis and Treatment. Neurology International [Internet]. 2023 Aug 31[cited 2025 May 03];15(3):1052–105. Available from:
https://doi.org/10.3390/neurolint15030067
37. Yadav S, Schanz R, Maheshwari A, Khan MS, Slark J, de Silva R. Bio-Repository of DNA in stroke (BRAINS): a study protocol. BMC medical genetics [Internet]. 2011 Mar 02 [cited 2025 May 03]; 12:34. Available from:
https://doi.org/10.1186/1471-2350-12-34
38. Voigt I, Inojosa H, Dillenseger A, Haase R, Akgün K, Ziemssen T. Digital Twins for Multiple Sclerosis. Frontiers in Immunology [Internet]. 2021 May 03 [cited 2025 May 03]; 12:669811. Available from:
https://doi.org/10.3389/fimmu.2021.669811
39. Wei W, Ma D, Li L, Zhang L. Progress in the Application of Drugs for Treatment of Multiple Sclerosis. Frontiers in Pharmacology [Internet]. 2021 Jul 13 [cited 2025 May 03];12: 724718. Available from:
https://doi.org/10.3389/fphar.2021.724718
40. Pucci E, Giuliani G, Solari A, Simi S, Minozzi S, di Pietrantonj C, et al. Natalizumab for relapsing remitting multiple sclerosis. The Cochrane database of systematic reviews [Internet]. 2011 Oct 05 [cited 2025 May 03]; (10):CD007621. Available from:
https://doi.org/10.1002/14651858.cd007621.pub2
41. Talanki Manjunatha R, Habib S, Sangaraju SL, Yepez D, Grandes XA. Multiple Sclerosis: Therapeutic Strategies on the Horizon. Cureus Journal of Medical Science [Internet]. 2022 May [cited 2025 May 03];14(5):24895.
Available from: https://doi.org/10.7759/cureus.24895
42. Farrugia M, Baron B. The role of TNF-α in rheumatoid arthritis: a focus on regulatory T cells. Journal of clinical and translational research [Internet]. 2016 Nov 10 [cited 2025 May 03];2(3):84–90. Available from:
http://dx.doi.org/10.18053/jctres.02.201603.005
43. Zhu Y, Zhu L, Wang X, Jin H.RNA-based therapeutics: an overview and prospectus. Cell death and disease [Internet]. 2022 Jul 23[cited 2025 May 03];13(7):644. Available from:
https://doi.org/10.1038/s41419-022-05075-2
44. Hoffmann B, Mayatepek E. Fabry disease-often seen, rarely diagnosed. Deutsches Arzteblatt international [Internet]. 2009 Jun [cited 2025 May 03];106(26):440–7.
Available from: https://doi.org/10.3238/arztebl.2009.0440
45. Segal JP, LeBlanc JF, Hart AL. Ulcerative colitis. Lancet [Internet]. 2023 [cited 2025 May 03];402(10376):1–2. Available from:
https://doi.org/10.1016/s0140-6736(23)00966-2
46. Rudrapatna VA, Velayos F. Biosimilars for the Treatment of Inflammatory Bowel Disease. Practical gastroenterology [Internet]. 2019 Apr [cited 2025 May 03];43(4):84–91. Available from:
https://pmc.ncbi.nlm.nih.gov/articles/PMC6703165/
47. Veauthier B, Hornecker JR. Crohn’s Disease: Diagnosis and Management. American family physician [Internet]. 2018 Dec 1[cited 2025 May 03];98(11):661–9. Available from:
https://pubmed.ncbi.nlm.nih.gov/30485038/
48. Yeshi K, Ruscher R, Hunter L, Daly NL, Loukas A, Wangchuk P. Revisiting Inflammatory Bowel Disease: Pathology, Treatments, Challenges and Emerging Therapeutics Including Drug Leads from Natural Products. Journal of clinical medicine [Internet]. 2020 Apr 28 [cited 2025 May 03];9(5):1273. Available from:
https://doi.org/10.3390/jcm9051273
49. Jussila A, Virta LJ, Pukkala E, Färkkilä MA. Mortality and causes of death in patients with inflammatory bowel disease: a nationwide register study in Finland. Journal of Crohn’s & colitis [Internet]. 2014 Sep [cited 2025 May 03];8(9):1088–96. Available from:
https://doi.org/10.1016/j.crohns.2014.02.015
50. Llerena JC, Horovitz DM, Marie SKN, Porta G, Giugliani R, Rojas MVM, et al. The Brazilian consensus on the management of Pompe disease. The Journal of pediatrics [Internet]. 2009 Oct [cited 2025 May 03];155(4 Suppl):S47-56. Available from:
https://doi.org/10.1016/j.jpeds.2009.07.006
51. Dornelles AD, Junges APP, Krug B, Gonçalves C, de Oliveira Junior HA, Schwartz IVD. Efficacy and safety of enzyme replacement therapy with alglucosidase alfa for the treatment of patients with infantile-onset Pompe disease: a systematic review and metanalysis. Frontiers in Pediatrics [Internet]. 2024 Feb 15 [cited 2025 May 03]; 12:1310317.
Available from: https://doi.org/10.3389/fped.2024.1310317
52. Taverna S, Cammarata G, Colomba P, Sciarrino S, Zizzo C, Francofonte D, et al. Pompe di sease: pathogenesis, molecular genetics and diagnosis. Aging [Internet]. 2020 Aug 03[cited 2025 May 03];12(15):15856–74.
Available from: https://doi.org/10.18632/aging.103794
53. Moravej H, Karamizadeh Z, Paran M. The Outcome of Infantile Onset Pompe Disease in South of Iran. Iranian journal of pediatrics [Internet].2016 Feb [cited 2025 May 03];26(1):4473. Available from:
https://doi.org/10.5812/ijp.4473
54. Peters H, Ellaway C, Nicholls K, Reardon K, Szer J. Treatable lysosomal storage diseases in the advent of disease-specific therapy. Internal medicine journal [Internet].2020 Nov[cited 2025 May 03];50 (Suppl 4):5–27.
Available from: https://doi.org/10.1111/imj.15100
55. D’Avanzo F, Rigon L, Zanetti A, Tomanin R. Mucopolysaccharidosis Type II: One Hundred Years of Research, Diagnosis, and Treatment. International journal of molecular sciences [Internet]. 2020 Feb 13 [cited 2025 May 03];21(4):1258.
Available from: https://doi.org/10.3390/ijms21041258
56. Zapolnik P, Pyrkosz A. Gene Therapy for Mucopolysaccharidosis Type II-A Review of the Current Possibilities. International journal of molecular sciences [Internet]. 2021 May 23[cited 2025 May 03]; 22(11):5490.
Available from: https://doi.org/10.3390/ijms22115490
57. Rake JP, Visser G, Labrune P, Leonard JV, Ullrich K, Smit GPA. Guidelines for management of glycogen storage disease type I – European Study on Glycogen Storage Disease Type I (ESGSD I). European Journal of Pediatrics [Internet]. 2002 Nov [cited 2025 May 03];161 (Suppl 1): 112-9. Available from:
https://doi.org/10.1007/s00431-002-1016-7
58. Pinto C, Sousa D, Ghilas V, Dardis A, Scarpa M, Macedo MF. Acid Sphingomyelinase Deficiency: A Clinical and Immunological Perspective. International journal of molecular sciences [Internet]. 2021 Nov 28 [cited 2025 May 03]; 22(23):12870. Available from:
https://doi.org/10.3390/ijms222312870
59. Sözen T, Özışık L, Başaran NÇ. An overview and management of osteoporosis. European journal of rheumatology [Internet]. 2017 Mar [cited 2025 May 03];4(1):46–56. Available from:
https://doi.org/10.5152/eurjrheum.2016.048
60. Zeghoud S, ben Amor I, Alnazza Alhamad A, Darwish L, Hemmami H. Osteoporosis therapy using nanoparticles: a review. Annals of medicine and surgery [Internet]. 2012 Jan [cited 2025 May 3];86(1):284–91. Available from:
https://doi.org/10.1097/ms9.0000000000001467
61. Chen LR, Ko NY, Chen KH. Medical Treatment for Osteoporosis: From Molecular to Clinical Opinions. International journal of molecular sciences [Internet]. 2019 May 6 [cited 2025 May 03]; 20(9):2213. Available from:
https://doi.org/10.3390/ijms20092213
62. Guimaraes TAC de, Georgiou M, Bainbridge JWB, Michaelides M. Gene therapy for neovascularage-related macular degeneration: rationale, clinical trials and future directions. The British journal of ophthalmology [Internet]. 2021 Feb [cited 2025 May 03];105(2):151–7. Available from:
https://doi.org/10.1136/bjophthalmol-2020-316195
63. Ferris FL, Wilkinson CP, Bird A, Chakravarthy U, Chew E, Csaky K, et al. Clinical classific ation of age-related macular degeneration. Ophthalmology [Internet]. 2013 Apr [cited 2025 May 03];120(4):844–51. Available from:
https://doi.org/10.1016/j.ophtha.2012.10.036
64. Leung MYM, Pollack LM, Colditz GA, Chang SH. Life years lost and lifetime health care expenditures associated with diabetes in the U.S., National Health Interview Survey, 1997-2000. Diabetes care [Internet]. 2015 Mar [cited 2025 May 03];38(3):460–8. Available from:
https://doi.org/10.2337/dc14-1453
65. Cerdá C, Camps J. Oxidative stress and DNA damage in obesity-related tumorigenesis. In: Camps J, editor. Oxidative stress and inflammation in non-communicable diseases: molecular mechanisms and perspectives in therapeutics. Cham: Springer; 2014. p. 21–39.
Doi:10.1007/978-3-319-07320-0_2.
66. Włodarczyk M, Nowicka G. Obesity, DNA Damage, and Development of Obesity-Related Diseases. International journal of molecular sciences [Internet]. 2019 Mar 06 [cited 2025 May 03]; 20(5):1146.
Available from: https://doi.org/10.3390/ijms20051146
67. Caserta MT, O’Leary ST, Munoz FM, Ralston SL, O’Leary ST, Campbell JD, et al. Palivizu mab Prophylaxis in Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection. Pediatrics [Internet]. 2023 Jul 01 [cited 2025 May 03];152 (1): e2023061803.
Available from: https://doi.org/10.1542/peds.2023-061803
68. Pelaia C, Crimi C, Vatrella A, Tinello C, Terracciano R, Pelaia G. Molecular Targets for Biological Therapies of Severe Asthma. Frontiers in immunology [Internet]. 2020; [cited 2025 May 03] 11:603312.
Available from:
https://doi.org/10.3389/fimmu.2020.603312
69. Pelaia C, Vatrella A, Bruni A, Terracciano R, Pelaia G. Benralizumab in the treatment of severe asthma: design, development and potential place in therapy. Drug design, development and therapy [Internet]. 2018 [cited 2025 May 03]; 12:619–28.
Available from: https://doi.org/10.2147/dddt.s155307
70. Lowes MA, Suárez-Fariñas M, Krueger JG. Immunology of psoriasis. Annual review of immunology [Internet]. 2014 [cited 2025 May 03]; 32:227–55.
Available from: https://doi.org/10.1146/annurev-immunol-032713-120225
71. di Cesare A, di Meglio P, Nestle FO. The IL-23/Th17 axis in the immunopathogenesis of psoriasis. The Journal of investigative dermatology [Internet]. 2009 Jun [cited 2025 May 03];129(6):1339–50.
Available from: https://doi.org/10.1038/jid.2009.59
72. Pavli P, Triantafyllidou O, Kapantais E, Vlahos NF, Valsamakis G. Infertility Improvement after Medical Weight Loss in Women and Men: A Review of the Literature. International journal of molecular sciences [Internet]. 2024 Feb 05[cited 2025 May 03];25(3).
Available from: https://doi.org/10.3390/ijms25031909
73. Fu Q, Hu L, Shen T, Yang R, Jiang L. Recent Advances in Gene Therapy for Familial Hypercholesterolemia: An Update Review. Journal of clinical medicine [Internet]. 2022 Nov 16 [cited 2025 May 03]; 11(22):6773.
Available from: https://doi.org/10.3390/jcm11226773
74. Khan S, Ullah MW, Siddique R, Nabi G, Manan S, Yousaf M, et al. Role of r-DNA Technology to Improve Life. International journal of genomics [Internet].2016[cited 2025 May 03]; 2016:2405954. Available from:
https://doi.org/10.1155/2016/2405954
75. Chheda U, Pradeepan S, Esposito E, Strezsak S, Fernandez-Delgado O, Kranz J. Factors Affecting Stability of RNA – Temperature, Length, Concentration, pH, and Buffering Species. Journal of Pharmaceutical Sciences [Internet]. 2024 Feb [cited 2025 May 03];113(2):377–85.
Available from: https://doi.org/10.1016/j.xphs.2023.11.023
76. Sanjeev S, Sharma S, Gupta R. Regulatory aspects for biologic product licensing in India. International Journal of Drug Regulatory Affairs [Internet]. 2019 [cited 2025 May 03];7(1):1-5. Available from:
https://doi.org/10.22270/ijdra.v7i1.287
77. Pemmasani SK, Raman R, Mohapatra R, Vidyasagar M, Acharya A. A Review on the Challenges in Indian Genomics Research for Variant Identification and Interpretation. Frontiers in genetics [Internet]. 2020 [cited 2025 May 03]; 11:753. Available from:
https://doi.org/10.3389/fgene.2020.00753
78. Ghagne S, Nerli R, Baligar P, Hiremath M. Status and Application of Recombinant DNA Therapeutic Products Used in Clinical Practices: An Indian Scenario. Social Science Research Network Electronic Journal [Internet]. 2016 [cited 2025 May 03] 2016: 2783940.
Available from: https://dx.doi.org/10.2139/ssrn.2783940
79. Uppal A, Chakrabarti R, Chirmule N, Rathore A, Atouf F. Biopharmaceutical Industry Capability Building in India: Report from a Symposium. Journal of Pharmaceutical Innovation [Internet]. 2022 [cited 2025 May 03]; 17(4):1555–62. Available from:
https://doi.org/10.1007/s12247-021-09596-9
80. Avhad VR, Patil SB. A Comparison of US, Europe, Japan and India Biosimilar Regulation. International Journal of Drug Regulatory Affairs [Internet]. 2025 Mar 15 [cited 2025 May 03];13(1):34-9. Available from:
https://www.ijdra.com/index.php/journal /article/view/745
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Dwivedi U, Mehta P, Patel S. Approval Trends of Recombinant DNA (r-DNA) Therapeutics in India: A Five- Year Review. Int J Drug Reg Affairs [Internet]. 2025Jun.15 [cited 2026Jan.31];13(2):60-2. Available from: https://www.ijdra.com/index.php/journal/article/view/760
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