Dr Reddy’s Laboratories has signed a licence agreement with Shanghai Henlius Biotech to develop and commercialise HLX15, a daratumumab biosimilar candidate to Johnson & Johnson’s (J&J) Darzalex & Darzalex Faspro.
Darzalex & Darzalex Faspro are indicated to treat multiple myeloma.
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The partnership leverages Dr. Reddy’s worldwide commercial network along with Henlius’ expertise in biosimilar development.
A recombinant anti-CD38 fully human monoclonal antibody injection, HLX15 comes in both intravenous and subcutaneous formulations.
Henlius will oversee development, manufacturing and supply, with potential earnings of up to $131.6m, including an upfront payment of $33m along with milestone payments.
It is also set to obtain royalties on HLX15’s annual net sales. Dr Reddy’s will have exclusive commercialisation rights for the candidate in the US and Europe.
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By GlobalDataDr Reddy’s CEO Erez Israeli stated: “We are pleased to collaborate with Henlius to make this daratumumab biosimilar available to patients in the US and Europe. Over the years, we have created a portfolio of biosimilar products that are being marketed in several emerging markets.
“The launch of our pegfilgrastim through our collaborator in the US in 2023, and bevacizumab in the UK last year, marked the start of our biosimilars journey in regulated markets.”
By following a stepwise approach, HLX15’s development aligns with the biosimilar guidelines set by regulatory authorities including the European Medicines Agency, the US Food and Drug Administration (FDA), and the National Medical Products Administration (NMPA).
A Phase I study of the biosimilar, concluded in June 2024, achieved its primary endpoint, demonstrating similar safety, immunogenicity and pharmacokinetics to the reference candidate sourced from the European Union, China, and the US. Further comparative efficacy studies are in progress.
In August 2024, Dr Reddy’s and its division Aurigene Pharmaceutical Services entered a non-binding memorandum of understanding with Kainomyx to jointly develop and commercialise an accessible anti-malarial drug.
