Dr. Reddy’s Laboratories Ltd.* has taken another strategic step in its biosimilars journey with a new collaboration with Shanghai Henlius Biotech. The agreement grants Dr. Reddy’s exclusive rights to commercialize HLX15, Henlius’ investigational daratumumab biosimilar candidate to Darzalex® and Darzalex Faspro®, in the U.S. and Europe. HLX15 is being developed in both subcutaneous and intravenous formulations for the treatment of multiple myeloma, with Henlius overseeing development, manufacturing, and supply.
The deal highlights Dr. Reddy’s growing focus on biosimilars in regulated markets, building on its existing portfolio in emerging markets. The agreement grants Dr. Reddy’s exclusive rights to commercialize HLX15, Henlius’ investigational daratumumab biosimilar candidate to Darzalex® and Darzalex Faspro®, in the U.S. and Europe, with Henlius receiving an upfront payment of $33 million and potential milestone payments totaling up to $131.6 million, along with royalties based on annual net sales.
Erez Israeli, CEO of Dr. Reddy’s Laboratories emphasized that the collaboration with Henlius is part of Dr. Reddy’s broader strategy to accelerate growth in the oncology space, particularly within hematologic malignancies where daratumumab plays a critical role, aligning with the company’s efforts to expand its oncology portfolio and enhance access to affordable therapies. He noted that the U.S. and European markets represent significant opportunities given the rising incidence of multiple myeloma and the growing demand for cost-effective biosimilar alternatives.
While the Henlius collaboration marks a significant milestone, it also reflects Dr. Reddy’s broader ambitions in the biosimilars space. Dr. Reddy’s has been steadily building its biosimilars presence, particularly in regulated markets. The launch of pegfilgrastim in the U.S. in 2023 and bevacizumab in the UK were key milestones, demonstrating the company’s ability to penetrate competitive markets with complex biologics. Recently, the company secured Marketing Authorization for Rituximab in the UK and from the European Commission for Europe, marking another milestone in its biosimilars journey.
Additionally, the company’s partnership with Alvotech for the commercialization of a denosumab biosimilar in the U.S. and Europe, which has been recently filed as part of Dr. Reddy’s envisaged plan, reflecting steady progress in the company’s biosimilars strategy in regulated markets U.S. and Europe underscores its commitment to expanding in high-growth therapeutic areas. Additionally, Dr. Reddy’s is advancing its development of Abatacept, which is expected to present a meaningful market opportunity due to anticipated limited competition. This product is entirely developed in-house, covering R&D, manufacturing, and commercialization. Having successfully completed Phase I, the company is now in Phase III trials, with regulatory filing anticipated by the end of this calendar year, targeting a potential market launch around late 2026 or early 2027.
Dr. Reddy’s biosimilars strategy is rooted in a multi-pronged approach: investing in R&D, expanding manufacturing capacities, forming strategic collaborations, and building its global commercial infrastructure. The company’s biosimilars strategy is centered on a limited portfolio of carefully selected assets within oncology, autoimmune diseases, and other high-burden conditions, where it believes it has a greater chance of success. This focused approach has driven its portfolio development, with several biosimilars now in advanced stages of regulatory review or awaiting approval.
In their latest earnings call, Israeli highlighted the company’s disciplined approach to biosimilars, emphasizing not just market entry but sustainable growth. The collaboration with Henlius complements this vision, offering Dr. Reddy’s an opportunity to strengthen its oncology pipeline while capitalizing on Henlius’ expertise in biosimilar development. He also noted that the biosimilars business has the potential to deliver long-term value through both revenue growth and margin expansion, supported by efficient supply chains and strong partnerships.
Looking ahead, Dr. Reddy’s has highlighted the company’s plans to continue expanding its biosimilars footprint, both through internal development and strategic partnerships. This latest collaboration with Henlius is more than just a licensing deal—it’s part of a broader strategy to establish Dr. Reddy’s as a key player in the global biosimilars market, delivering on its mission to improve patient access to affordable, high-quality biologics.
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