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Dr. Reddy’s has secured exclusive U.S. and Europe commercialization rights for Henlius’s daratumumab biosimilar HLX15 in a deal worth up to $131.6 million. The drug, aimed at treating multiple myeloma, showed promising Phase 1 results and is now undergoing global Phase 3 trials.
On 6 February 2025, Dr. Reddy’s Laboratories SA (Société Anonyme, a French term meaning "public limited company), a wholly owned subsidiary of Dr. Reddy’s Laboratories Ltd., formed a major licensing partnership with Shanghai Henlius Biotech, Inc. to commercialize HLX15—a proposed biosimilar of daratumumab—across the highly regulated pharmaceutical markets of the United States and Europe.
This agreement marks a fundamental step in expanding access to affordable oncology treatments in regulated markets. Daratumumab is a type of monoclonal antibody that binds to CD38, a protein frequently found in high levels on multiple myeloma cells. HLX15, developed by Henlius, is being investigated as a biosimilar version of the widely used anti-cancer therapies.
Key Details of the Partnership
As per the terms of the agreement, Dr. Reddy’s will receive exclusive commercialization rights for both the intravenous and subcutaneous formulations of HLX15 in the U.S. and Europe. Henlius will maintain responsibility for the product’s ongoing development, clinical trials, manufacturing, and global supply chain management. Dr. Reddy’s will handle regulatory submissions and all commercialization efforts in the partnered territories.
The financial structure of the deal encompasses an upfront payment of $33 million from Dr. Reddy’s to Henlius. The total deal value could reach up to $131.6 million, with the remainder comprising development and commercial milestone payments. Additionally, Henlius will receive tiered royalties based on net product sales once HLX15 enters the market.
Clinical Progress and Regulatory Pathway
HLX15 has already completed a phase 1 clinical trial, in which it illustrated similar pharmacokinetic properties, safety, and immunogenicity compared to the reference daratumumab product. These results support HLX15's potential as a high-quality biosimilar. A global Phase 3 comparative efficacy study is currently underway to further validate therapeutic equivalence in multiple myeloma-affected patients.
Strategic Importance for Both Companies
This collaboration represents the third biosimilar partnership between Dr. Reddy’s and Henlius, following earlier agreements for rituximab and bevacizumab. It highlights the shared goal of expanding access to advanced biologic therapies in markets where affordability and availability remain key challenges.
Market Potential
Daratumumab is a blockbuster oncology drug with billions in annual sales, utilized extensively in first-line and relapsed settings for multiple myeloma. The introduction of a cost-effective biosimilar like HLX15 has the potential to remarkably minimize treatment costs and expand patient access across the globe. The agreement also places Dr. Reddy’s in a dominant position to tap into the multi-billion-dollar biosimilar market in the U.S. and Europe.
Dr. Reddy's Press Release
Dr. Reddy’s enters into collaboration with Henlius for commercialization of HLX15 (daratumumab), a biosimilar candidate to Darzalex® & Darzalex Faspro® in the U.S., and Europe
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