Amneal Launches First Biosimilar with ALYMSYS® (bevacizumab-maly) in the United States

First of three approved U.S. oncology biosimilars Amneal expects to launch

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the commercial launch of ALYMSYS^® (bevacizumab-maly), a biosimilar referencing Avastin^®. ALYMSYS^® is a vascular endothelial growth factor inhibitor used in oncology. This product was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals.

“The launch of ALYMSYS provides additional access and choice to affordable oncology therapeutics for providers and patients. As a new entrant to the fast growing $28 billion U.S. biosimilars market, we are leveraging our commercial expertise in the Buy and Bill injectable space and have built a dedicated biosimilar commercial team. We look to be an exceptionally customer centric organization and support stable, system wide adoption of ALYMSYS and our biosimilars to come as a long-term player in this space,” said Harsher Singh, SVP of Amneal Biosciences.

“Amneal has officially entered the U.S. biosimilar market. Beyond these initial launches, we are working to expand our biosimilars portfolio with additional molecules where we can be early to market and vertically integrate over time. Biosimilars represent the next wave of affordable medicines and are closely aligned with our mission to provide high quality, affordable medicines to as many patients as possible,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

According to IQVIA^®, U.S. annual sales for bevacizumab for the 12 months ended July 2022 were $2.4 billion, $1.7 billion of which represented biosimilar sales.

About ALYMSYS

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.

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 over 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, strategies, 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, including pro forma results; impact of acquisitions and dispositions, and estimated returns or assumptions underlying acquisitions and dispositions; the Company’s strategy for growth; regulatory approvals and actions; market position, saturation, 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; the competition we face in the pharmaceutical industry in general, including from brand and generic drug product companies, and the impact of that competition on our ability to execute on pricing strategies; our ability to obtain exclusive marketing rights for our products; 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 continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods and any associated supply chain disruptions; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or curb Amneal’s ability to sell its products; the impact of severe weather; the impact of the ongoing COVID-19 pandemic; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; 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; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; the impact of global economic conditions, including any economic effects stemming from adverse geopolitical events, an economic downturn and inflation rates; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; 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; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. 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.

Anthony DiMeo
Head of Investor Relations
anthony.dimeo@amneal.com