Home / Health / Cheaper Cancer Drug Incoming: India Gears Up for Keytruda Clones
Cheaper Cancer Drug Incoming: India Gears Up for Keytruda Clones
16 Apr
Summary
- Indian manufacturers are developing generic Keytruda versions.
- Patent expiry in June 2028 could halve drug costs.
- Government scheme aims to boost domestic biosimilar production.
With Merck & Co's Keytruda patent expiring in June 2028, at least seven Indian manufacturers are poised to develop generic versions. This development offers hope for significantly reduced costs for the expensive cancer immunotherapy drug, which currently costs over Rs 3 lakh per dose in India. Experts anticipate that the entry of biosimilars could lead to price drops of up to 70%, making the treatment more accessible.
The Indian government is actively supporting this shift through the Rs 10,000-crore Bio Pharma SHAKTI scheme, launched in March, aimed at building a domestic ecosystem for biosimilars and decreasing import dependence for high-cost drugs. Focus areas include cancer and autoimmune disorders. Companies like Sun, Hetero, and Intas are among those pursuing generic versions, with trials for pembrolizumab also underway by international firms.
Challenges remain, however. Merck & Co holds numerous global patents related to Keytruda, potentially creating legal hurdles for biosimilar producers, as seen with similar drugs like nivolumab. The lengthy process for biosimilar approval in India, requiring full clinical trials, also adds significant cost and time compared to international standards. Streamlining these trials and actively supporting indigenous development are seen as crucial steps.
