Posted by Michael Wonder on 19 Jan 2019
Samsung Bioepis biosimilar to Roche's Herceptin wins FDA nod
19 January 2019 - The U.S. FDA said on Friday it had approved a biosimilar to Roche’s blockbuster breast cancer treatment, Herceptin.
The biosimilar, Ontruzant, is sold by Merck Sharp & Dohme, a unit of Merck & Co, and is developed by Samsung Bioepis, which is a joint venture between Samsung BioLogics and Biogen Inc.
The approval here comes just a few weeks after the health regulator gave Celltrion's Herzuma - another biosimilar to Herceptin - its nod to market it commercially.
