Indian pharma cos to benefit as US proposes tweaks in biosimilar approval guidelines

A new draft guidance published by the US drug regulator (US FDA) on October 29 to facilitate the development and faster approval of biosimilar drugs (low cost alternative to biologic medicines that treat serious and chronic diseases) in that country could benefit Indian biosimilar drug manufacturers in a big way.

The draft proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing. The US FDA has stated that the agency, through a separate initiative, also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily.

Indian Pharmaceutical Alliance (IPA), the representative body of leading domestic pharmaceutical companies, has welcomed the move. “India already has nearly 130 approved biosimilars, and over the next seven years, more than 55 blockbuster drugs are expected to lose exclusivity in the US. India has long been a trusted partner in ensuring access to quality-assured, affordable medicines for American patients. These reforms will further strengthen the US–India partnership and our shared goal of improving healthcare access and affordability”, Sudarshan Jain, Secretary General, IPA said.

A statement issued by US FDA noted that expensive biologic medications make up only 5% of prescriptions in the U.S. but account for 51% of total drug spending as of 2024. It pointed out that FDA-approved biosimilars are as safe and effective as the branded drugs, yet their market share remains below 20%. “To date, FDA has approved 76 biosimilars, corresponding to a small fraction of approved biologics. By contrast, there are more than 30,000 approved generics, exceeding the number of approved brand drugs. Only about 10% of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development”, the agency said in a press release.

The approval pathway for biosimilars was established by the U.S. Congress in 2010 through the Biologics Price Competition and Innovation Act (BPCIA) to promote competition in markets dominated by high-cost biologics. Since then, the US FDA has approved 76 biosimilars that provide Americans additional treatment options for conditions such as cancer, rheumatoid arthritis, diabetes, Crohn’s disease, and osteoporosis.  With the current draft, the US drug regulator aims to help more companies bring affordable, high-quality biosimilars to market and reduce costs for the American people.