The FDA approved the first 2 biosimilars referencing aflibercept (Eylea). (aflibercept). However, patent litigation has left it unclear when the biosimilars will come to market.
Both approvals were supported by comparative clinical trials, as well as studies that evaluated the products on an analytical level using physicochemical tests and biological assays.
The US Food and Drug Administration (USFDA) has approved the company s first-to-file application for Yesafili, a vascular endothelial growth factor inhibitor used to treat several different types of ophthalmology conditions, the company said in a statement.
International Business News: NEW DELHI: Biocon Biologics announced that the US Food and Drug Administration (US FDA) has approved the company's application for YESAFILI, the compa.