Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA

Rhea-AI Summary

Amneal Pharmaceuticals (AMRX) announced FDA acceptance of Biologics Licensing Applications (BLA) for two denosumab biosimilar candidates referencing Prolia® and XGEVA®. The FDA's target action date is set for Q4 2025.

The biosimilars are developed through a partnership with mAbxience, where mAbxience handles development and manufacturing while Amneal manages regulatory approval and U.S. commercialization. These candidates represent Amneal's next potential biosimilar launches, adding to their current portfolio of three commercialized biosimilars.

Denosumab is a monoclonal antibody that inhibits bone reabsorption, used for bone metastasis from cancer and prevention of bone-related injuries including osteoporosis. The U.S. market for Prolia® and XGEVA® reached approximately $5.0 billion in annual sales for the 12 months ended December 2024.

Amneal aims to expand its portfolio to six biosimilars across eight product presentations by 2027, strengthening its position in the U.S. biosimilars market.

Positive

• FDA acceptance of two new biosimilar applications
• Large market opportunity: $5.0B annual sales potential
• Strategic partnership with established manufacturer mAbxience
• Portfolio expansion from 3 to 6 biosimilars by 2027
• Building on previous successful biosimilar launches

Negative

• Long waiting period until potential approval (Q4 2025)
• Competitive market with established reference products
• Known serious adverse reactions in reference products

Insights

Financial Analyst

The FDA's acceptance of Amneal's BLA for two denosumab biosimilars is a significant regulatory milestone that substantially advances the company's biosimilar strategy. With a target FDA action date in Q4 2025, these products represent Amneal's potential entry into a $5 billion annual U.S. market currently dominated by Prolia® and XGEVA®.

This development aligns perfectly with Amneal's stated roadmap of expanding from three currently marketed biosimilars to six biosimilars across eight product presentations by 2027. The strategic partnership with mAbxience leverages complementary strengths - mAbxience handles development and manufacturing while Amneal manages regulatory approval and commercialization rights in the U.S.

Denosumab represents a high-value target in the biosimilar space due to its dual applications in oncology (preventing skeletal-related events in cancer patients) and osteoporosis treatment. This BLA acceptance follows the partners' previous success with ALYMSYS®, a bevacizumab biosimilar launched in 2022.

While BLA acceptance represents a de-risking event in the regulatory pathway, final approval remains contingent on the FDA's Q4 2025 decision. Nevertheless, this progress positions Amneal to potentially capture meaningful market share in a substantial therapeutic category, strengthening their growing biosimilar portfolio.

Denosumab biosimilar candidates reference Prolia^® and XGEVA^®

Amneal looks to expand portfolio to six biosimilars across eight product presentations by 2027

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, and mAbxience (“mAbxience”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics Licensing Application (BLA) for two proposed denosumab biosimilars referencing Prolia^® and XGEVA^®. mAbxience is a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma. Fresenius Kabi is an operating company of Fresenius.

The FDA has assigned a target action date in the fourth quarter of 2025. Currently, Amneal commercializes three biosimilars in the U.S., with the two denosumab biosimilar candidates representing its next potential biosimilar launches. Additionally, three more biosimilars are in development, positioning Amneal to have a portfolio of six biosimilars across eight product presentations by 2027.

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 is responsible for the development and manufacturing of the biosimilars while Amneal will pursue regulatory approval and have exclusive commercialization rights in the United States. Amneal and mAbxience currently partner on ALYMSYS^®, a bevacizumab biosimilar, which was launched in 2022.

“Amneal is building its position in the U.S. biosimilars market as this next wave of affordable medicines increases access for patients to biologics. Building on our first three successful biosimilar launches, we look to expand our portfolio next with denosumab, which is an important therapy across multiple indications, including oncology. We are pleased to expand our partnership with mAbxience as we advance our biosimilars pipeline,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal.

“We have a longstanding and productive partnership with Amneal, and we are pleased to be advancing these two important products to the U.S. biosimilar market. We remain focused on our globalization strategy and applying innovation and cutting-edge R&D technology to create high quality, affordable medicines for underserved patients,” said Jurgen Van Broeck, Chief Executive Officer of mAbxience.

Prolia^®: In patients with postmenopausal osteoporosis, the most frequently reported adverse reactions included back musculoskeletal and extremity pain; hypercholesterolemia; and cystitis. Among male patients with osteoporosis, back pain, arthralgia, and nasopharyngitis were reported. Prolia also carries a Boxed Warning for patients with advanced chronic kidney disease.

XGEVA^®: The most frequently reported serious adverse reaction was dyspnea. Other reported adverse reactions observed included fatigue, asthenia, hypophosphatemia, and nausea. Discontinuation was reported in patients with osteonecrosis and hypocalcemia.

According to IQVIA^®, U.S. annual sales for Prolia^® and XGEVA^® for the 12 months ended December 2024 were approximately $5.0 billion.

About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines 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. 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 and follow us on LinkedIn.

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, an operating company of Fresenius, acquired a majority stake of mAbxience, making it a global, vertically integrated 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.

Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250303452981/en/

Investor Contact

Anthony DiMeo

VP, Investor Relations

anthony.dimeo@amneal.com

mAbxience Contact

Miguel Martínez-Cava

Global External Communication Manager

miguel.martinezcava@mabxience.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

When is the FDA target action date for Amneal's denosumab biosimilars (AMRX)?

The FDA has set a target action date in the fourth quarter of 2025 for both denosumab biosimilar candidates.

What is the current market size for Prolia and XGEVA that Amneal (AMRX) is targeting?

U.S. annual sales for Prolia® and XGEVA® were approximately $5.0 billion for the 12 months ended December 2024.

How many biosimilars does Amneal (AMRX) currently commercialize in the US?

Amneal currently commercializes three biosimilars in the U.S. market.

What is Amneal's (AMRX) biosimilar portfolio target by 2027?

Amneal aims to have a portfolio of six biosimilars across eight product presentations by 2027.

What is the partnership structure between Amneal (AMRX) and mAbxience for these biosimilars?

mAbxience is responsible for development and manufacturing, while Amneal handles regulatory approval and exclusive U.S. commercialization rights.