Update on Biosimilar Approvals and Pending Applications in Europe and the U.S.

June 6, 2017

Approvals of biosimilar products in Europe continue to outpace those in the United States. Currently, 28 biosimilars are approved in Europe and five in the U.S. In 2017, the European Medicines Agency (EMA) has ap­proved six biosimilar applications, including applica­tions for biosimilars to two of the best-selling complex biologics, Humira (adalimumab) and MabThera (rituximab). The EMA is likely to approve seven more biosimilar applications in the coming months. The U.S. Food and Drug Administration in turn has approved one biosimilar this year, and an agency advisory com­mittee in late May recommended approval of Pfizer’s proposed biosimilar of Amgen’s EPO (epoetin alfa), which the agency previously rejected. Proposed biosimilars of complex biologics in a number of new classes are pending before both agencies at the same time.

To continue reading Irena Royzman and Jake Siegel’s article from Bloomberg BNA’s Life Sciences Law & Industry Report, please click here.