Biogen Adds To Biosimilar Anti-TNF Portfolio In Europe With Flixabi
Samsung Bioepis’s biosimilar infliximab, Flixabi, has been approved for marketing in Europe, where it will add to Biogen's marketed biosimilar TNF-inhibitor etanercept to give the company two cost-effective TNF-inhibitors to offer to patients and hard-pressed healthcare systems.
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If the FDA approves Samsung Bioepis' and Merck's biosimilar version of Remicade, known as SB2, which is now under review at the agency, the firms not only will have Janssen Biotech Inc. to contend with, but Celltrion and Pfizer Inc., which won approval last month of the first infliximab biosimilar in the US.
April saw the 10th anniversary of the first biosimilar approval in Europe –Sandoz International GMBH's Omnitrope (somatropin) – which was launched in 2006. But a decade on, even with 20 biosimilar products now available and many more to come as big biological drugs lose their patent protection, there are still significant barriers to biosimilar penetration and wide variations in patient access across the EU that need to be addressed.
Move over Zarxio. There's a new kid in town: Inflectra (infliximab-dyyb), which won the FDA's nod on April 5 as the first monoclonal antibody biosimilar licensed in the US, although it's going to be a while before patients have access to the new drug, since Celltrion Inc. and Pfizer Inc. said they won't put it on the market until after June 29.