A biosimilar boost amid trade barriers

Amidst the uncertainty of 50 per cent tariffs on India, the US FDA's October 29 draft guidance reducing the need for comparator efficacy studies for biosimilars comes as a welcome silver lining. Though the tariffs do not as yet apply to generics, the uncertainty has been a drag on the Q2FY2026 performances of most pharma companies in India.

- VIVEKA ROYCHOWDHURY, Editor [e-mail] [e-mail]

Amidst the uncertainty of 50 per cent tariffs on India, the US FDA's October 29 draft guidance reducing the need for comparator efficacy studies for biosimilars comes as a welcome silver lining. Though the tariffs do not as yet apply to generics, the uncertainty has been a drag on the Q2FY2026 performances of most pharma companies in India.

Which is why the US FDA's new guidance got positive reviews from India Pharma Inc. As the US FDA press release points out, despite requiring one to three years and costing $24 million on average, comparative efficacy studies generally have low sensitivity compared to many other analytical assessments. The FDA's new guidance reduces this unnecessary resource-intensive requirement for developers to conduct comparative human clinical studies, allowing them to rely instead on analytical testing to demonstrate product differences.

It's a move that will slash development costs and result in more affordable biosimilar medicines for the US market. For biopharma companies, that spells better margins and more incentive to invest in biosimilars.

The draft guidance is part of President Trump's Make America Healthy Again (MAHA) plan. The US FDA release points out that biologic medications make up only five per cent of prescriptions in the US but account for 51 per cent of total drug spending as of 2024.