Cipla and Qilu partner on Keytruda biosimilar for U.S. market

  • Invagen Pharmaceuticals and Qilu Pharmaceutical entered an exclusive U.S. partnership for QL2107.
  • Qilu will handle development, regulatory registration and supply; Cipla USA will commercialize QL2107.
  • Merck is expected to lose Keytruda patent protection in 2028.

Invagen Pharmaceuticals, a wholly owned subsidiary of India’s Cipla, has entered an exclusive U.S. licensing and supply partnership with China’s Qilu Pharmaceutical for QL2107, a biosimilar to pembrolizumab, marketed as Merck’s Keytruda. Qilu will oversee development, regulatory registration and supply, while Cipla USA will commercialize the product by using its U.S. commercial presence. The agreement supports Cipla’s plan to expand its oncology-focused biosimilars portfolio and Qilu’s effort to combine its research and manufacturing capabilities with a U.S. commercial partner. QL2107 is intended to broaden access to a potentially lower-cost biologic treatment, subject to regulatory approval. Keytruda is used across multiple cancer indications, and Merck is expected to lose patent protection for the drug in 2028.

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