Center for Biosimilars Reports Biosimilar Regulatory Landscape Increasingly Complex

Mar 22, 2019 | Biosimilars, Regulations

The Center for Biosimilars reports biosimilar developers face a global landscape but dealing with localized regulations becomes quite complex.  During the first day of the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Barbara Valenta-Singer, MD, chief medical officer of biosimilars at Fresenius-Kabi SwissBioSim, gave an expert perspective on the past 10-plus years of experience with biosimilars in the European and US contexts.

Valenta-Singer began her presentation with a discussion of the first biosimilar approved in the European Union: Omnitrope, a biosimilar somatropin that gained European Medicines Agency (EMA) clearance in 2006. In the United States, the drug was approved 2 years later, though there was no biosimilar approval pathway in the United States at the time, and the drug is therefore considered a follow-on in the United States rather than a biosimilar.  We include the rest of the Center for Biosimilar summary of the event. Follow the link below.