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HYDERABAD, India — Dr. Reddy’s Laboratories SA has entered into a license agreement with Shanghai Henlius Biotech Inc. for the commercialization of HLX15 (daratumumab), a biosimilar candidate to Johnson & Johnson’s Darzalex and Darzalex Faspro.
Darzalex and Darzalex Faspro are indicated for the treatment of multiple myeloma. HLX15 is a recombinant anti-CD38 fully human monoclonal antibody injection, with intravenous as well as subcutaneous formulations.
The agreement combines Dr. Reddy’s global commercial presence with Henlius’ proven capabilities in developing biosimilars for markets worldwide. Under the terms of the agreement, Henlius will be responsible for development, manufacturing and commercial supply, and may receive up to $131.6 million, including an up-front payment of $33 million and milestone payments. In addition, Henlius is eligible to receive royalties on annual net sales of the product. Dr. Reddy’s gets exclusive rights to commercialize the subcutaneous as well as intravenous formulations of HLX15 in the United States and Europe.
“We are pleased to collaborate with Henlius to make this daratumumab biosimilar available to patients in the U.S. and Europe,” said Dr. Reddy’s chief executive officer Erez Israeli. “Over the years, we have created a portfolio of biosimilar products that are being marketed in several emerging markets. The launch of our pegfilgrastim through our collaborator in the U.S. in 2023, and bevacizumab in the United Kingdom last year marked the start of our biosimilars journey in regulated markets. Last year, we also signed a collaboration with Alvotech for the commercialization of their denosumab biosimilar in the U.S. and Europe. This latest collaboration with Henlius further progresses our regulated markets journey in biosimilars. Additionally, oncology has been a top focus therapy area for us. We look forward to leveraging our strong commercial capabilities in these markets to ensure patients receive access to best-in-class therapies and affordable treatment options.”
“This collaboration with Dr. Reddy’s on HLX15 is a significant step in our response to global health needs and improving access to advanced biologics,” said Henlius executive director and chief executive officer Dr. Jason Zhu. “Dr. Reddy’s has a long-standing dedication to oncology, driven by the purpose of ‘Good Health Can’t Wait,’ and is committed to timely access to affordable and high-quality medicines which complement Henlius’ focus on addressing unmet medical needs in research and development. We are confident that this partnership will enhance the global market competitiveness of both organizations in oncology treatment, ultimately allowing us to reach and support more patients around the world.”
In accordance with the biosimilar guidelines of China’s National Medical Products Administration, the European Medicines Agency, and the Food and Drug Administration, HLX15 is being developed following the principles of stepwise development. HLX15 and reference daratumumab are considered comparable, based on analytical similarity assessment and pre-clinical studies. In June, the Phase 1 clinical study (NCT05679258) of HLX15 was successfully completed, meeting its primary endpoint. The findings indicate that HLX15 had similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the U.S.-, EU- and CN-sourced daratumumab. Comparative efficacy studies are under way.
