Dr Reddy's and Henlius ink deal for HLX15

Dr. Reddy’s Laboratories has entered a strategic partnership with Shanghai Henlius Biotech to advance and bring to market HLX15, a promising biosimilar candidate to the well-known Johnson & Johnson drugs, Darzalex and Darzalex Faspro. These medications are used in the treatment of multiple myeloma, a type of blood cancer. This collaboration aims to combine Dr. Reddy's extensive global marketing reach with Henlius’ expertise in biosimilar development.

HLX15 is a recombinant anti-CD38 fully human monoclonal antibody injection, available in both intravenous and subcutaneous forms. As part of the agreement, Henlius will handle the development, manufacturing, and supply of HLX15. The financial terms of the deal include potential earnings of up to $131.6 million, which encompasses an upfront payment of $33 million and additional milestone payments. Furthermore, Henlius is set to receive royalties based on the annual net sales of HLX15. Dr. Reddy’s will hold exclusive rights to commercialize the biosimilar in the United States and Europe.

Erez Israeli, the CEO of Dr. Reddy’s, expressed enthusiasm about the collaboration with Henlius, highlighting the opportunity to make the daratumumab biosimilar accessible to patients in the US and Europe. He emphasized the company’s growing portfolio of biosimilar products, which are already available in several emerging markets. The launch of biosimilars such as pegfilgrastim in the US in 2023 and bevacizumab in the UK last year signified the commencement of Dr. Reddy’s biosimilars journey in highly regulated markets.

The development of HLX15 is proceeding in line with the stringent biosimilar guidelines established by leading regulatory bodies, including the European Medicines Agency, the US Food and Drug Administration (FDA), and the National Medical Products Administration (NMPA). A Phase I study of HLX15, completed in June 2024, successfully achieved its primary goals by demonstrating comparable safety, immunogenicity, and pharmacokinetics to those of the reference drug sourced from the European Union, China, and the US. Additional studies comparing efficacy are currently underway to further validate the biosimilar's performance.

In an unrelated venture, Dr. Reddy’s, along with its division Aurigene Pharmaceutical Services, signed a non-binding memorandum of understanding with Kainomyx in August 2024. This agreement focuses on the joint development and commercialization of a new and affordable anti-malarial drug, showcasing Dr. Reddy’s commitment to addressing a variety of global health challenges beyond oncology.

This new agreement between Dr. Reddy’s and Henlius represents a significant step forward in the development of biosimilars, aiming to provide more affordable options for patients suffering from multiple myeloma. Through this partnership, the companies hope to enhance the accessibility of crucial cancer treatments across key markets, while also continuing to broaden their respective portfolios in the biopharmaceutical landscape.