At its meeting on 22 April 2026, the Subject Expert Committee (SEC) under India’s Central Drugs Standard Control Organisation (CDSCO) recommended approval of Enzene’s Phase 3 clinical trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of biosimilar pembrolizumab in comparison with MSD’s Keytruda® (pembrolizumab) in combination with pemetrexed and platinum based chemotherapy in adult patients with metastatic non-small cell lung cancer.
The clinical trial protocol was revised after the SEC instructed Enzene to make changes to the protocol in December 2025, including as to its primary endpoint, non-inferiority margin used for sample size calculation, length of safety assessment and clinical trial sites.
Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025). Pembrolizumab biosimilars are also under development including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, BioNTech, Alvotech, Formycon and Amneal/Kashiv.