Govt Set to Roll Out Stricter Norms for Biosimilar Approvals

The Indian government is putting final touches on revised regulations to tighten quality requirements for biosimilar medicines, treatments derived from living cells applied in the treatment of cancers and autoimmune diseases. The new 'Guidelines on Similar Biologics,' now under public consultation, will come closer to international regulatory standards. This is the second significant revamp since the guidelines were first introduced in 2012 and revised in 2016.

Major proposals involve exempting animal toxicology studies and comparative clinical trials where there is strong global data and analytical similarity. This comes after the US FDA's decision to phase out animal testing for monoclonal antibodies, using more sophisticated methods.

“The review would provide an opportunity to evaluate new developments and identify areas where the current guidance could be more flexible without compromising its basic principles and allow for the provision of additional explanation of the possibility of tailoring the amount of data needed for regulatory approval,” according to the draft guidelines.

It seeks to restrict use of animals in testing. “The 3Rs principles for animal experiments (replace, reduce, refine) should always be followed to minimize the use of animals in testing,” it said.

As per the draft guidelines, animal models are often not sensitive enough to detect small differences. “If a relevant and sufficiently sensitive in-vivo animal model cannot be identified, the manufacturer may choose to proceed directly to clinical studies, taking into account strict principles to mitigate any potential risk,” it said.

India's biosimilar market stood at USD 867 million in 2024 and is anticipated to grow at a rate of 17% per annum. Existing norms mandate scientific rationale for selected animal models in toxicity tests, subject to approval by the Review Committee on Genetic Manipulation (RCGM).

Industry players are advocating for more dependence on analytical and pharmacokinetic and pharmacodynamic (PK/PD) studies and clearer approval schedules and simplified inter-agency coordination. They've also requested redefining the RCGM's role, recommending it to handle early-stage innovation and not repeat approvals of biologics already approved in regulated markets such as the US and EU.