On October 12, 2023 mAbxience (a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma) has reported an exclusive licensing agreement with Amneal Pharmaceuticals, Inc. (NYSE: AMRX), an integrated specialty pharmaceutical company powered by a robust U.S. generics business, to commercialize two denosumab biosimilars in the U.S. market (Press release, mAbxience, OCT 12, 2023, View Source [SID1234635885]).
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Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries.
Under the terms of the agreement, mAbxience will conduct the full development of the two biosimilars candidates and manufacture them in its state-of-the-art, Good Manufacturing Practice (GMP)-approved facilities, while Amneal will guide the products through regulatory approval and have exclusive commercialization rights in the United States. The financial terms of the transaction were not disclosed.
This partnership with Amneal not only bolsters mAbxience’s footprint in the U.S. market, but also fortifies the successful collaboration with Amneal, initiated in 2018 with an exclusive agreement for bevacizumab.
"We are thrilled to strengthen our partnership with Amneal through this second agreement, marking a significant step forward in our shared mission to enhance global health. This collaboration will bring two world-class biosimilars for the treatment of bone diseases and oncology to patients across the U.S., reinforcing our commitment to ensuring worldwide access to high-quality, life-enhancing treatments. Together with Amneal, we continue to make strides in offering affordable and accessible healthcare solutions, contributing positively to public health and solidifying our presence in the global biosimilar space," said Emmanuelle Lepine, Chief Executive Officer, mAbxience.
"Our goal is to be a top five player in the U.S. biosimilar space, similar to our leadership position in U.S. retail generics. Biosimilars represent the next wave of affordable medicines and these new product opportunities are aligned with our strategy to provide high quality, essential therapies," said Harsher Singh, Senior Vice President, Amneal Biosciences. "Our first three commercial U.S. biosimilars are doing very well as our excellent commercial team drives uptake in these competitive categories. We are pleased to partner again with mAbxience on these next two biosimilar candidates, which deepens our pipeline and expands our presence in oncology."
According to IQVIA, U.S. annual sales for Prolia and XGEVA for the 12 months ended August 2023 were approximately $4.4 billion.
The American Cancer Society estimates that in 2023, there will be over 1.9 million new cancer cases diagnosed. Beyond cancer, in the United States, the incidence of bone diseases is a growing concern. In 2010, it was estimated that a staggering 10.2 million adults were diagnosed with osteoporosis, with women constituting over 80% of this demographic[1]. This alarming trend is set to continue, with projections indicating a 310% increase in hip fractures for men and a 240% rise for women by 2050[2], a grave consequence of osteoporosis. This scenario underscores the palpable urgency for effective and accessible treatments to mitigate the impact of these conditions on the lives of millions. The commitment to advancing healthcare solutions for oncology and bone diseases remains paramount, aiming to significantly reduce its incidence and provide a better quality of life for all.