U.S. FDA approves first biosimilar rival to Roche’s blockbuster eye drug
U.S. FDA approves first biosimilar rival to Roche’s blockbuster eye drug
September 20, 2021; 8:20 AM EDT
(Reuters) – The U.S. Food and Drug Administration on Monday approved South Korean drugmaker Samsung Bioepis Co Ltd and Biogen Inc’s (BIIB.O) biosimilar rival to Roche Holding AG’s (ROG.S) blockbuster eye drug, Lucentis.
Biosimilars are cheaper versions of biologic drugs made from living organisms.
Lucentis, which already faces competition from Novartis AG’s (NOVN.S) Beovu, is approved to treat eye diseases such as wet age-related macular degeneration and brought in sales of CHF 1.4 billion ($1.50 billion) in 2020.
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
The copycat version will be allowed to be marketed in the United States from next year June, as part of an agreement with Roche’s Genentech unit, the drug developers said in a joint statement.
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