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16 September 2026

Cipla And Qilu Announce Exclusive U.S. Licensing And Supply Agreement For Pembrolizumab Biosimilar

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InvaGen Pharmaceuticals Inc., a Cipla Limited subsidiary, has entered into a strategic partnership with Qilu Pharmaceutical Co., Ltd. for the licensing and supply of QL2107, a biosimilar to Merck's KEYTRUDA® (pembrolizumab), in the United States. This collaboration represents the latest in a series of partnering transactions directed to pembrolizumab biosimilar candidates, with Qilu handling development and regulatory registration while Cipla USA manages commercialization.
United States Food, Drugs, Healthcare, Life Sciences
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On September 3, 2026, InvaGen Pharmaceuticals Inc., a wholly owned subsidiary of Cipla Limited, announced a strategic partnership and exclusive license with Qilu Pharmaceutical Co., Ltd. for the licensing and supply of QL2107, a biosimilar to Merck’s KEYTRUDA® (pembrolizumab), in the United States. Pembrolizumab is a humanized monoclonal antibody that binds the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing the inhibitory signal that suppresses the T-cell antitumor response. KEYTRUDA is approved for the treatment of a wide range of solid tumors and hematologic malignancies.

According to the announcement, Qilu “will be responsible for development, regulatory registration and supply of the product while Cipla USA Inc. will be responsible for the commercialization of the asset by leveraging its strong commercial presence in the defined territory.” The companies did not disclose financial terms.

The agreement is the latest in a series of partnering transactions directed to pembrolizumab biosimilar candidates. As we previously reported, Formycon AG and Lotus Pharmaceutical executed an exclusive license agreement in February 2026 covering Formycon’s pembrolizumab biosimilar candidate, FYB206, in the Asia-Pacific region.

Stay tuned to Big Molecule Watch for further developments involving pembrolizumab biosimilars.

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