- Biosimilar candidates referencing Prolia®
and XGEVA®
- Builds on first year success of Amneal’s
initial three biosimilar launches
- Expands existing biosimilar partnership
with mAbxience
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) today announced the addition of two denosumab
biosimilars referencing both Prolia® and XGEVA® to its biosimilar
pipeline.
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.
The two denosumab products are being developed by mAbxience, a
global biotech company with over a decade of experience in the
development, manufacture, and commercialization of
biopharmaceuticals. Under the terms of the agreement, mAbxience
will fully develop the biosimilar molecule and manufacture it in
its state-of-the-art, Good Manufacturing Practice (GMP)-approved
facilities, while Amneal will guide the product through regulatory
approval and have exclusive commercialization rights in the United
States. Amneal and mAbxience also currently partner on ALYMSYS®, a
bevacizumab biosimilar.
“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.”
“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.
According to IQVIA®, U.S. annual sales for Prolia® and XGEVA®
for the 12 months ended August 2023 were approximately $4.4
billion.
The financial terms of the transaction were not disclosed, and
any incremental expenses associated with these products are
contemplated within Amneal’s guidance.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
Bridgewater, NJ, is a fully integrated global pharmaceuticals
company. We make healthy possible through the development,
manufacturing, and distribution of a diverse portfolio of
approximately 270 pharmaceutical products, primarily within the
United States. In its Generics segment, the Company is expanding
across a broad range of complex product categories and therapeutic
areas, including injectables and biosimilars. In its Specialty
segment, Amneal has a growing portfolio of branded pharmaceuticals
focused primarily on central nervous system and endocrine
disorders, with a pipeline focused on unmet needs. Through its
AvKARE segment, the Company is a distributor of pharmaceuticals and
other products for the U.S. federal government, retail, and
institutional markets. For more information, please visit
www.amneal.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20231012487822/en/
Investors Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
Amneal Pharmaceuticals (NYSE:AMRX)
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