Miami, FL /PRNewswire/ - Brand Institute is proud to announce its successful partnership with Amneal Pharmaceuticals in developing the brand name ALYMSYS®, under which the biosimilar approved by the Food and Drug Administration (FDA) on April 13, 2022 will be marketed. This biosimilar represents the third bevacizumab 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.
"The entire Brand Institute and Drug Safety Institute Team congratulates Amneal Pharmaceuticals and mAbxience on the FDA approval of ALYMSYS," said Brand Institute's Chairman and C.E.O., James L. Dettore.
About Brand Institute and our wholly owned regulatory subsidiary, Drug Safety Institute
Brand Institute is the global leader in pharmaceutical and healthcare-related name development, with a portfolio of over 3,800 marketed healthcare brand names, 1,200 USAN/INN nonproprietary names for 1,100 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers. Drug Safety Institute is composed of former naming regulatory officials from global government health agencies, including Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), American Medical Association (AMA), and the World Health Organization (WHO). These regulatory experts co-authored the name review guidelines while with their respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications. Now working for a private company, these professionals provide Brand Institute's clients with industry-leading guidance pertaining to drug name safety (i.e., preventing medication errors), packaging, and labeling.