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

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

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.