Amneal Biologics License Application for Bevacizumab Accepted by US FDA
17 June 2021 - - The US Food and Drug Administration has accepted for review the Biologics License Application for Bevacizumab, pursuant to Section 351(k) pathway of the Public Health Service Act, and with a standard review goal date in the second quarter of 2022 according to the BsUFA (Biosimilar User Fee Act), US-based Amneal Pharmaceuticals, Inc. (NYSE: AMRX) said.

The biosimilar was developed in collaboration with mAbxience, a Spain-based biotechnology company.

Bevacizumab is the biosimilar version of Avastin and when approved will be marketed under the proprietary name Alymsys.

Alymsys was approved by the European Medicines Agency in February 2021. Amneal and mAbxience believe that the data supports the biosimilarity of its Alymsys product to Avastin.

Bevacizumab is a vascular endothelial growth factor inhibitor.

Amneal is seeking approval for Bevacizumab for the treatment of metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment and 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 Alymsys-containing regimen.

Amneal also plans to seek approval for the remainder of the indications from the reference product label as soon as possible, subject to patent and regulatory exclusivities, by the biosimilarity pathway pursuant to Section 351(k).

According to IQVIA, a leading healthcare data and analytics provider, US annual sales for Bevacizumab for the 12 months ended April 2021 were approximately USD 2.8bn.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug products.

The company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.

Amneal has a portfolio of approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a broad range of therapeutic areas.

The company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

The company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs.

AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing.