Amneal Achieves Second U.S. Biosimilars Approval with ALYMSYS® (bevacizumab-maly)

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Biologics License Application (BLA) for bevacizumab-maly, a biosimilar referencing Avastin^®. The product will be marketed under the proprietary name ALYMSYS^® and represents the third bevacizumab biosimilar approved in the U.S.

ALYMSYS^® was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. Bevacizumab-maly is a vascular endothelial growth factor inhibitor used in oncology. This marks the second of three biosimilars approvals Amneal expects to receive this year in oncology, the second-largest biosimilar category in the U.S. Earlier this year, Amneal received approval of RELEUKO^® (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen^®, and the Company’s pegfilgrastim biosimilar referencing Neulasta^® is currently under review by the FDA.

“With the U.S. approval of our second biosimilar, ALYMSYS^®, we are continuing our momentum and establishing our presence in the $28 billion U.S. biosimilars market. By combining partner assets with our own key capabilities, we are on a clear path to becoming a meaningful player in this high growth category. Biosimilars represent the next wave of affordable medicines in the U.S. and are closely aligned with our strategy to provide high quality, affordable medicines to as many patients as possible,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

“Through our strategic partnership with a market leader like Amneal, we are excited to see this important product enter the U.S. biosimilar market. For us, this is a great example of our globalization strategy materializing and how innovation and cutting-edge R&D technology can be applied to create high quality, affordable medicines that improve access to critical treatments,” said Emmanuelle Lepine, Chief Executive Officer of mAbxience.

According to IQVIA^®, U.S. annual sales for bevacizumab for the 12 months ended February 2022 were $2.6 billion, $1.6 billion of which represented biosimilar sales.

ALYMSYS^® (bevacizumab-maly) in the U.S. is a vascular endothelial growth factor inhibitor indicated for the treatment of:

• Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first or second-line treatment.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
• First-Line non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel.
• Recurrent glioblastoma in adults.
• Metastatic renal cell carcinoma in combination with interferon alfa.
• Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel

Limitations of Use: ALYMSYS^® is not indicated for adjuvant treatment of colon cancer.

ALYMSYS^® IMPORTANT SAFETY INFORMATION includes warnings and precautions on severe and fatal hemorrhage; arterial and venous thromboembolic events; hypertension, hypertensive crisis, and hypertensive encephalopathy; renal injury, proteinuria, and nephrotic syndrome; posterior reversible encephalopathy syndrome; embryo-fetal toxicity; ovarian failure; congestive heart failure; gastrointestinal perforations and fistula; surgery and wound healing complications, and infusion-related reactions.

ADVERSE REACTIONS

Reported adverse drug reactions in patients include epistaxis, hemorrhage, hypertension, exfoliative dermatitis, proteinuria, back pain, headache, rhinitis, taste alteration, dry skin, and lacrimation disorder.

For full prescribing information, see package insert located here.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of approximately 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products 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, please visit www.amneal.com.

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 or forecasts for the future, including among other things: product research and development; discussions of future operations; expected operating results and financial performance; the Company’s strategy for growth; regulatory approvals; market position and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates” and similar words are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; including risks and uncertainties regarding the launch timing and commercial success of ALYMSYS^® and other biosimilar products; the competition we face in the pharmaceutical industry from brand and generic drug product companies; the impact of global economic conditions; direct or indirect impacts of the ongoing COVID-19 pandemic; our ability to obtain exclusive marketing rights for our products; the impact of competition on our ability to set prices; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to FDA product approval requirements; risks related to federal regulation of arrangements between manufacturers of branded and generic products; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; the continuing trend of consolidation of certain customer groups; our reliance on certain licenses to proprietary technologies from time to time; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our dependence on third-party agreements for a portion of our product offerings; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the significant amount of resources we expend on research and development; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; and the impact of severe weather. 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. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. 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.

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