Dr Reddy’s Collaborates with Henlius for HLX15 Biosimilar Commercialisation

Dr Reddy’s Laboratories SA, a wholly owned subsidiary of Dr Reddy’s Laboratories Ltd, has entered into a licensing agreement with Shanghai Henlius Biotech, Inc. for the development and commercialisation of HLX15, a biosimilar candidate to Darzalex® and Darzalex Faspro.

Under this agreement, Dr Reddy’s will hold exclusive rights to commercialise HLX15 in the United States and Europe, marking a significant step in its expansion within regulated biosimilar markets.

Agreement and Financial Details

The agreement aligns Dr Reddy’s extensive commercial reach with Henlius’ expertise in biosimilar development. Henlius will oversee development, manufacturing, and commercial supply, while Dr. Reddy’s will focus on marketing and distribution. 

Henlius stands to receive up to $131.6 million, including a $33 million upfront payment and milestone-based payments. Additionally, Henlius will earn royalties on annual net sales of HLX15. The deal reinforces Dr Reddy’s strategy of expanding its biosimilar portfolio in major global markets.

HLX15 and Its Role in Oncology

HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody, developed as a biosimilar to Darzalex and Darzalex Faspro, used in the treatment of multiple myeloma. It is available in both intravenous and subcutaneous formulations. 

HLX15 has undergone analytical similarity assessments, pre-clinical studies, and a successful Phase 1 clinical study in June 2024, which demonstrated comparable pharmacokinetics, safety, and immunogenicity to the reference daratumumab sourced from the US, EU, and China. Comparative efficacy studies are ongoing.

Dr Reddy Share Performance

As of February 07, 2025, at 3:17 PM, the shares of Dr Reddy are trading at ₹1,240.15 per share up by 0.28% from its previous day’s closing price.

Conclusion

This collaboration between Dr. Reddy’s and Henlius enhances their global position in oncology biosimilars, ensuring greater accessibility to advanced biologics. With Dr. Reddy’s established commercial network and Henlius’ biosimilar expertise, the partnership strengthens both companies’ presence in the regulated pharmaceutical markets of the US and Europe.

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