• Biosimilar candidates referencing Prolia® and XGEVA®
  • Amneal will guide the products through regulatory approval and have exclusive commercialization rights in the U.S.
  • mAbxience will conduct the development of the two denosumab products and manufacture and supply the commercial products for Amneal

mAbxience (a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma) has announced today 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.

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.

About mAbxience
mAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. In August 2022, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi acquired a majority stake of mAbxience, making it a global, vertically integrated fully-fledged biotechnology company. With over a decade of expertise, our mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines. With two market-approved products and a robust pipeline in development, we have established a B2B presence in over 100 markets. Alongside this, we have formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Our three multi-product facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions. For more insights into mAbxience, our biosimilars and CDMO business, please visit our website (www.mabxience.com) or connect with us on LinkedIn.

[1] International Osteoporosis Foundation. IOF COMPENDIUM OF OSTEOPOROSIS (Page 17). Available from: https://www.osteoporosis.foundation/sites/iofbonehealth/files/2020-01/IOF-Compendium-of-Osteoporosis-web-V02.pdf

[2] International Osteoporosis Foundation. EPIDEMIOLOGY OF OSTEOPOROSIS AND FRAGILITY FRACTURES https://www.osteoporosis.foundation/facts-statistics/epidemiology-of-osteoporosis-and-fragility-fractures