India-based Cipla Limited (BSE: 500087; NSE: CIPLA) has secured exclusive US commercialization rights for QL2107, a biosimilar to pembrolizumab (Keytruda), through an exclusive licensing and supply agreement with China-based Qilu Pharmaceutical. Financial terms were not disclosed.
Under the agreement, Qilu retains full responsibility for development, regulatory registration, and supply of QL2107, while Cipla's US subsidiary will handle commercialization exclusively in the United States.
QL2107 is a monoclonal antibody biosimilar targeting PD-1, the immune checkpoint receptor targeted by Merck's Keytruda. The asset is currently in Phase III development, with a trial in metastatic non-squamous non-small cell lung cancer initiated in January 2025. No clinical data have been disclosed.
The pembrolizumab biosimilar space is among the most competitive in the industry, with at least a dozen programs in active development globally. Germany-based Formycon's FYB206 is among the most advanced candidates, having demonstrated pharmacokinetic equivalence to Keytruda in a pivotal study; Formycon has said a Phase III efficacy study is not required following regulatory feedback. The company partnered with Zydus for US and Canadian commercialization in December 2025. Samsung Bioepis also has an active biosimilar pembrolizumab program with preliminary Phase I data reported in May 2026. QL2107 is therefore entering a crowded development race ahead of the expected loss of key US exclusivity for Keytruda toward the end of the decade, potentially in 2028, although the timing of individual biosimilar launches will depend on regulatory progress and the resolution of relevant patent rights.