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Big Molecule Watch
February 14, 2025

Dr. Reddy’s Secures License from Henlius to Market Daratumumab Biosimilar in the U.S. and Europe

On February 6, 2025, Dr, Reddy’s Laboratories SA (“Dr. Reddy’s”) announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. (“Henlius”) for the development and commercialization of Henlius’s HLX15 (daratumumab), a biosimilar candidate to Janssen’s Darzalex® & Darzalex Faspro®.  HLX15 (daratumumab) is a recombinant anti-CD38 fully human monoclonal antibody indicated for the treatment of multiple myeloma.  The agreement grants Dr. Reddy’s the exclusive rights to commercialize the subcutaneous and intravenous formulations of HLX15 in the United States and Europe, while Henlius will be responsible for development, manufacturing, and commercial supply.  Under the agreement, Henlius may receive up to $131.6 million, including an upfront payment of $33 million and milestone payments.  Henlius will also be eligible to receive royalties on annual net sales of the product.

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