Amneal Pharmaceuticals and mAbxience have entered into an exclusive licensing agreement for the development and commercialisation of two denosumab biosimilars.

Spain-headquartered mAbxience will develop and manufacture the two biosimilars while Amneal will oversee the candidates through US regulatory approval pathways. Amneal will also have exclusive commercialisation rights in the US, based on a 12 October Amneal press release.

The deal, the financial terms of which were not disclosed, adds to an already established collaboration between the two companies. In May 2018, they signed an exclusive licensing and supply agreement for the development of bevacizumab, a biosimilar to Genetech (Roche’s) Avastin. Avastin is approved for use in cancers such as ovarian cancer and advanced cervical cancer. In April 2022, the US Food and Drug Administration approved the companies’ Avastin biosimilar, which is marketed under the name ALYMSYS.

In the 12 October statement, Amneal referenced Amgen’s denosumab products Prolia and Xgeva. The two drugs saw global sales of $3.6bn and $2bn, respectively, as reported in Amgen’s full-year financial results.

Denosumab is a monoclonal antibody for the treatment of osteoporosis. Prolia is approved for use in men and women who require increased bone mass while receiving therapy for prostate cancer and breast cancer, respectively. It is also indicated for the treatment of postmenopausal women with osteoporosis. Xgeva is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone cancer.

Earlier this year, Amneal launched Fylnetra – a biosimilar to Amgen’s Neulasta (pegfilgrastim), as its third US biosimilar. Amneal also rolled out Releuko, a filgrastim biosimilar to Amgen’s Neupogen, in November 2022.

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Amneal Biosciences’senior vice-president Harsher Singh said: “Our goal is to be a top-five player in the US biosimilar space. Biosimilars represent the next wave of affordable medicines and these new product opportunities are aligned with our strategy to provide high-quality, essential therapies.”

This content was updated on 25 January 2024