News | May 2, 2022

FDA Approves Alymsys® (bevacizumab-maly), A Bevacizumab Biosimilar Developed By mAbxience

Miami, FL. /PRNewswire/ - Brand Institute is proud to announce its successful partnership with mAbxience in the development of the ALYMSYS® brand, under which the Food and Drug Administration (FDA)-approved biosimilar on 13 April 2022 will be marketed by Amneal Pharmaceuticals LLC. This biosimilar represents the third bevacizumab approved in the United States.

ALYMSYS® was developed by mAbxience, a global biotechnology company with more than a decade of experience in developing, manufacturing and marketing biopharmaceuticals. Bevacizumab-maly is a vascular endothelial growth factor inhibitor used in oncology.

"The entire team at the Brand Institute and the Drug Safety Institute congratulates mAbxience and Amneal on the FDA approval of ALYMSYS," said Brand Institute President and CEO James L. Dettore .

About the Brand Institute and our regulatory affiliate, the Drug Safety Institute
Brand Institute is the world leader in the development of pharmaceutical and healthcare-related names, with a portfolio of more than 3,800 traded healthcare brand names and 1,200 USAN/INN nonproprietary names for 1,100 clients. The company is involved in more than 75% of pharmaceutical brand and nonproprietary name approvals worldwide with medical device manufacturers each year. The Drug Safety Institute is comprised of former regulatory officials from government health agency designations around the world, including the Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC ), the American Medical Association ( AMA) and the World Health Organization (WHO). These regulatory experts co-authored name review guidelines while working at their respective agencies, and many of them were responsible for ultimately approving (or rejecting) brand name applications. Now working for a private company, these professionals provide Brand Institute clients with industry-leading guidance on drug naming safety (i.e., prevention of medication errors), packaging, and the labeling.

Source: Brand Institute, Inc.

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