Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of India-based Dr. Reddy’s Laboratories Ltd. has entered into a license agreement with Shanghai Henlius Biotech, Inc. related to the development and commercialisation of HLX15, Henlius’s investigational daratumumab biosimilar candidate to Darzalex & Darzalex Faspro.
HLX15 is a recombinant anti-CD38 fully human monoclonal antibody injection, with intravenous as well as subcutaneous formulations. HLX15 is being developed as a biosimilar of Darzalex & Darzalex Faspro, which are indicated for the treatment of multiple myeloma.
The agreement combines Dr. Reddy’s global commercial presence with Henlius’ proven capabilities in developing biosimilars for markets worldwide. Under the terms of the agreement, Henlius will be responsible for development, manufacturing and commercial supply, and may receive up to a total of $131.6 million, including an upfront payment of $33 million and milestone payments.
In addition, Henlius is eligible to receive royalties on annual net sales of the product. Dr. Reddy’s gets exclusive rights to commercialise the subcutaneous as well as intravenous formulations of HLX15 in the United States (U.S.) and Europe.
Erez Israeli, Chief Executive Officer of Dr. Reddy’s, said, "This latest collaboration with Henlius further progresses our regulated markets journey in biosimilars. Additionally, oncology has been a top focus therapy area for us."
