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Drug Products: Biologics, Biosimilars and Interchangeables01:28

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Biosimilars in India; Current Status and Future Perspectives.

Bikash R Meher1, Sakthi Balan2, Rashmi R Mohanty3

  • 1Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.

Journal of Pharmacy & Bioallied Sciences
|March 26, 2019
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Summary

Biologic patents expiring by 2020 enable biosimilar development. India, a leading manufacturer, established new guidelines in 2012 for biosimilar pre- and post-marketing approval.

Keywords:
BiosimilarsEuropean Medicines AgencyFood and Drug Administrationsimilar biologics

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Area of Science:

  • Biopharmaceutical development
  • Regulatory science

Background:

  • Key biologic patents began expiring around 2020.
  • The market for biosimilars has grown significantly since the early 2000s.
  • India is a major global manufacturer of biosimilars.

Purpose of the Study:

  • To outline the regulatory landscape for biosimilars in India.
  • To highlight India's role in biosimilar manufacturing.

Main Methods:

  • Review of India's biosimilar regulatory guidelines.
  • Analysis of biosimilar market trends.

Main Results:

  • India introduced comprehensive guidelines in 2012 for biosimilar approval.
  • These guidelines cover both pre-marketing and post-marketing phases.
  • India is positioned as a key player in the global biosimilar market.

Conclusions:

  • India's regulatory framework supports the development and approval of biosimilars.
  • The country's manufacturing capabilities contribute to the increasing global use of biosimilars.