Biogen and Samsung land FDA approval for biosimilar to blockbuster Roche drug September 20, 2021 Auto Bot Biogen, Biologics, BioPharma, biopharma nl, Biosimilar, Cambridge, Clinical Trials, FDA, Legal, Massachusetts, Pharma, Samsung Bioepis, Samsung Biologics 0 The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic product have approval to treat three eye conditions that lead to vision loss.