CDSCO Eases Approval Process as Drugmakers Near Launch of Landmark HIV Drug
核心洞察
A CDSCO subject expert committee recommended on August 11 waiving local Phase III trials and bioequivalence studies for generic injectable lenacapavir, citing unmet medical need.
Emcure Pharmaceuticals (搜索) has filed its injectable version with the DCGI and expects approval by the end of the fiscal year, with Dr Reddy's Laboratories and Hetero also developing generics.
The generics are being developed under royalty-free voluntary licences from Gilead Sciences signed in 2024 covering 120 countries, with MSF expecting rollout in licensed low- and middle-income markets from 2027.
Indian manufacturers are moving closer to launching affordable generic versions of Gilead Sciences' long-acting HIV (搜索) drug lenacapavir after the subject expert committee of the Central Drugs Standard Control Organisation (搜索) (CDSCO) on August 11 recommended waiving local Phase III clinical trials and bioequivalence studies for the generic injectable, citing unmet medical need. The recommendation covers applications from Dr Reddy's Laboratories and Emcure Pharmaceuticals (搜索), though final regulatory authorisation is still required. The panel recommended post-marketing Phase IV studies in India.
Emcure has already filed its injectable version with the Drugs Controller General of India and is hopeful of approval by the end of the fiscal year, whole-time director and chief operating officer Samit Mehta said, adding that the company is responding to regulatory queries on priority. Emcure, Dr Reddy's and Hetero are among the Indian companies developing generic lenacapavir under royalty-free voluntary licences from Gilead signed in 2024 covering 120 countries, including India. Mehta cited a rule of thumb of around 12 months from filing to commercialisation, though expedited reviews for antiretroviral medicines could shorten that. Emcure is vertically integrated for the product, including its own active pharmaceutical ingredient, and has invested in capacity for the tablets used alongside the injection.
Public indications from Dr Reddy's and Hetero point to an annual treatment cost of around $40 for the twice-yearly injections and accompanying tablets, against $28,000 to $42,000 annually in developed markets. Dr Reddy's recently expanded its Gilead partnership to include the investigational once-yearly lenacapavir formulation. MSF said generic rollout across licensed low- and middle-income markets is expected from 2027, but cautioned that the CDSCO panel did not recommend a similar Phase III waiver for the treatment indication in heavily treatment-experienced people with multidrug-resistant HIV (搜索).
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