Indian pharma industry welcomes FDA move to accelerate biosimilar development

New Delhi: The U.S. Food and Drug Administration (FDA) has announced major reforms aimed at making biosimilar development faster and less costly, a move welcomed by global stakeholders, including the Indian pharmaceutical industry.

In a significant policy update, the FDA released a new draft guidance proposing major changes to simplify biosimilarity studies and reduce unnecessary clinical testing. The agency also outlined a plan to make it easier for biosimilars to be approved as interchangeable with brand-name biologics, a step expected to expand patient access to affordable biologic medicines.

“The recent announcement by the USFDA and CMS is a welcome step that will accelerate biosimilar development and lower drug costs for patients,” said Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance (IPA). “The simplification of interchangeability guidelines and approval pathways will create a more enabling environment for the industry to diversify in the large-molecule space.”

He added that India, with nearly 130 approved biosimilars, is well-positioned to contribute to this evolving landscape. “Over the next seven years, more than 55 blockbuster drugs are expected to lose exclusivity in the U.S. India has long been a trusted partner in ensuring access to quality-assured, affordable medicines for American patients. These reforms will further strengthen the U.S.–India partnership and our shared goal of improving healthcare access and affordability,” Jain said.

According to the FDA, biologic medications account for just 5% of U.S. prescriptions but represent over 50% of total drug spending as of 2024. While the agency has approved 76 biosimilars to date, they make up only a fraction of approved biologics. By contrast, there are more than 30,000 approved generic drugs in the U.S.

The new draft guidance, titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies,” is based on nearly a decade of accumulated data and experience since the approval of the first biosimilar in 2015. The FDA noted that comparative efficacy studies, which can take up to three years and cost around $24 million, often provide limited value relative to analytical testing. The updated guidance therefore allows developers to rely more on advanced analytical and functional assays instead of resource-intensive human trials.

The agency also clarified that it generally does not recommend switching studies — previously required for biosimilars seeking “interchangeable” designation — aligning biosimilars more closely with the regulatory expectations for generic drugs.

FDA Commissioner Dr. Marty Makary mentioned that streamlining biosimilar approvals would “achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions of Americans.”

Dr. George Tidmarsh, Director of the FDA’s Center for Drug Evaluation and Research, emphasized that the new policy reflects evolving science and the agency’s commitment to “advancing common-sense policies that promote efficient and effective biosimilar development without compromising safety and effectiveness.”

The Biologics Price Competition and Innovation Act (BPCIA), enacted in 2010, first established the U.S. approval pathway for biosimilars to encourage competition in markets dominated by high-cost biologics. The FDA’s latest reforms represent the most significant update to this framework since its inception and are expected to accelerate global momentum in biosimilar development — with India emerging as a key player in this next phase of biopharmaceutical innovation.