Regulatory architecture of biosimilars in Singapore: A critical overview

  • Soundarya Reddy Kalva Individual
  • Sahitya Reddy Kalva
  • Sudheer Kumar Gumme
DOI https://doi.org/10.22270/ijdra.v7i3.341

Abstract

A Biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorized (the „biological reference medicine‟). The expiration of the patents on many biological products has prompted the development of these products as similar biological products. The European Medicinal Agency (EMEA) has done a commendable job at creating the regulatory path to facilitate approval of biosimilars. The Health Product Act requires all medicinal products sold in Singapore and manufactured locally for export to be licensed with the Health Products Regulation Group, Health Science Authority (HAS). Biosimilar products are eligible for the New Drug Application (NDA-2 and NDA-3) application types. The Biosimilar product should be evaluated and approved by at least one of HAS‟s reference agencies namely Australia, Health Canada, Europe, United States. Approved biosimilars must be demonstrated, through extensive characterization and appropriate clinical trials, to be as safe and effective as originators for the benefit of patients.

Keywords: Biosimilars, Health Science Authority (HAS), NDA-2, NDA-3, EMEA, Clinical Trial Certificate (CTC), MAV, MIV

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References

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How to Cite
1.
Kalva SR, Kalva SR, Gumme SK. Regulatory architecture of biosimilars in Singapore: A critical overview. Int J Drug Reg Affairs [Internet]. 2019Sep.15 [cited 2025Apr.23];7(3):34-9. Available from: https://www.ijdra.com/index.php/journal/article/view/341
Issue
Vol 7 No 3 (2019): VOLUME 7, ISSUE 3, 2019
Section
Review
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