On 6 May 2025, India’s Central Drugs Standard Control Organization (CDSCO) published draft revised guidelines on biosimilars, which update marketing authorisation requirements for biosimilars in line with recent international guidelines. Given regulatory agencies of major countries are moving toward waiving non-clinical studies, the revisions focus on strengthening orthogonal analytical tools and in vitro studies to establish similarity between biosimilars and their reference products.
The revisions to the guidelines include the introduction of scientific considerations and key principles for licensing biosimilars; a revised pathway for approval of biosimilars in India; the introduction of “next generation analytical methodologies” to establish analytical similarity; and new guidance on determining the need for in vivo animal studies.
India’s biosimilar guidelines were last updated in 2016. Stakeholders have until 5 June 2025 to submit comments on the new draft in Word format to biological@cdsco.nic.in.
The publication of India’s revised draft biosimilar guidelines follow reviews being undertaking by US and EU regulatory agencies for the purpose of streamlining biosimilar development: in particular, the EMA’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars and the FDA’s 2024 guidance on biosimilar interchangeability.
