Europe approves its first mAb biosimilar & FDA is handling 17 biosimilar INDs

Not surprising after the European Medicines Agency (EMA) positive opinion for two biosimilars to Remicade (infliximab) in June, the first of these was authorized in September.  Authorization of Remsima represents the first monoclonal antibody biosimilar, and the thirteenth biosimilar, authorized in the European Union. In the United States, the Food and Drug Administration is into its third year of implementing its own biosimilars pathway.  At a recent meeting of the Regulatory Affairs Professional Society (RAPS), FDA Officials announced that they are working with biosimilar sponsors on a total of 17 Investigational New Drug applications (INDs) but have not yet received any biosimilar Biologics License Applications (BLA) under the 351(k) pathway.  FDA is also working diligently on the draft biosimilars guidances and plans to have final versions released within a year. The EMA also posts its general and product class specific biosimilar guidelines, including concept papers, drafts and final versions.

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