India releases guidelines on biosimilar approval, manufacturing

India's Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology have published guidelines on biosimilars that detail the regulatory path to marketing authorization. The 58-page "Guidelines on Similar Biologic" also details how reference products must be cited in applications as well as the eventual manufacturing process. "These guidelines are for the guidance of all stakeholders and are not meant to substitute or rephrase the rules made under Drugs & Cosmetics Act, 1940 or any other relevant Acts and are subject to being in conformity with the Drugs & Cosmetics Act and Rules as may be amended from time to time." Document (PDF)

 

Suggested Articles

Hengrui's Sun Piaoyang is stepping down as chairman, but he'll retain control of the pharma major he's headed for 30 years—and made a fortune…

Astellas tapped Adaptimmune to develop T-cell therapies. Ireland hit Takeda with an unexpected Shire tax bill. PD-1 med Tyvyt hit its goal in NSCLC.

South Korea’s Celltrion, which has a massive biologics site in Songdo, has decided it is time to build some operations in China.