On 3 September 2026, Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, announced that it has entered into a strategic partnership with China’s Qilu Pharmaceutical for the exclusive licensing and supply in the US of QL2107, biosimilar to MSD’s Keytruda® (pembrolizumab).
Under the agreement, Qilu is responsible for development, regulatory approval and supply of the product, while Cipla is responsible for US commercialisation.
Qilu commenced a Phase 3 study in January 2025 to compare the efficacy and safety of QL2107 vs Keytruda® in combination with chemotherapy in treating metastatic non-squamous non-small-cell lung cancer. The study has an estimated primary completion date of December 2026.
Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).
There are multiple pembrolizumab biosimilars in development with competition to be the first mover in major markets heating up. Samsung Bioepis and Celltrion each applied for Korean approval of their pembrolizumab biosimilars in August 2026 (SB27 and CT-P51, respectively). In June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results. Formycon announced successful Phase 1 results in February 2026, with its US commercialisation partner, Zydus, expressing optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab. Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region and Lotus for the Asia-Pacific.
Other companies with pembrolizumab biosimilars in clinical trials include Amgen, mAbxience, Sandoz, Shanghai Henlius, BioNTech, and Enzene. Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.