India Pharma Outlook Team | Wednesday, 07 May 2025
Comments have been invited from the stakeholders by the Central Drugs standard control organization (CDSCO) on the revised guidelines on biosimilars with updated requirements for marketing authorizations in the country, in line with the latest international guidelines.
The current scientific evidence and scientific updates from the international guidelines, primarily the guidelines on Evaluation of similar Biologics from WHO technical, report series, No. 1043, 2022 are considered by the guideline. The current revision focuses on strengthened orthogonal analytical tools and in vitro studies to establish similarity between the reference Biological product, as major countries are pursuing waivers for non-clinical studies for similar biologics in the health system.
The list of in vitro studies, the use of reference standards and the creation of in-house reference standards, next-generation analytical methodologies for establishing analytical similarity, and new guidelines for assessing the necessity of in vivo animal studies and implementing the 3Rs ( Replace, Reduce, Refine) principles to reduce the use of animals in testing are all covered. It should be mentioned that groups dedicated to preventing animal abuse have been calling for fewer animals to be used in drug testing, specifically as the pharmaceutical industry and academic institutions around the world are moving away from such procedures. "It was however viewed as a 'living' document that would be further revised in line with advances in scientific knowledge and experience," said the drug regulator.