Hyderabad: Dr Reddy’s Laboratories SA, the wholly-owned Swiss subsidiary of Hyderabad-based pharma giant Dr Reddy’s Laboratories Ltd, entered into a licence agreement with Shanghai Henlius Biotech Inc for the development and commercialisation of the Chinese player’s multiple myeloma treatment drug.
The deal gives Dr Reddy’s exclusive rights to commercialise subcutaneous and intravenous formulations of investigational daratumumab biosimilar candidate HLX15 in the United States and European markets.
A biosimilar is a biologic medication. It is highly similar to the original biologic (also called the reference product) medication already approved for use by competent authorities.
As part of the deal, Dr Reddy’s will pay Henlius up to $131.6 million (approx. 1,146 crore), which includes an upfront payment of $33 million (approx. 289 crore) as well as milestone payments. The Chinese player is also eligible to receive royalties on annual net sales of the product.
Henlius will be responsible for the development, manufacturing, and commercial supply of HLX15, which is being developed by as a biosimilar of Johnson & Johnson’s multiple myeloma treatment biologic drugs Darzalex and Darzalex Faspro.
“The agreement combines Dr Reddy’s global commercial presence with Henlius’ proven capabilities in developing biosimilars for markets worldwide,” Dr Reddy’s said in a regulatory filing on Thursday.
Dr Reddy’s Labs CEO Erez Israeli said the latest collaboration with Henlius progresses the company’s regulated markets journey in biosimilars, even as oncology has been a top focus therapy area for the company, which has created a portfolio of biosimilar products marketed in several emerging markets over the years.
“The launch of our pegfilgrastim through our collaborator in the US 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 commercialisation of their denosumab biosimilar in the US and Europe. 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,” he said.
“The collaboration with Dr Reddy’s on HLX15 is a significant step in our response to global health needs and improving access to advanced biologics. This partnership will enhance the global market competitiveness of both organisations in oncology treatment, ultimately allowing us to reach and support more patients around the world,” said Henlius executive director & CEO Dr Jason Zhu.
In June 2024, Henlius successfully completed the phase 1 clinical trial of HLX15, with the findings indicating that it had similar pharmacokinetic characteristics as well as comparable safety and immunogenicity profiles to the US, EU, and CN sourced daratumumab. The company is now conducting comparative efficacy studies.
