Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes and 16 biosimilar applications, including applications in four new product classes, are pending as of December 1, 2016. 2017 may see significant expansion of the biosimilars available in Europe.
Approved Biosimilar Products
The EMA approved four additional biosimilars in 2016, including three biosimilars in two new product classes: a biosimilar of Amgen’s Enbrel (etanercept) and two biosimilars of Sanofi’s Clexane (enoxaparin sodium). Etanercept is a fusion protein used to treat a variety of autoimmune disorders and enoxaparin sodium is a low-molecular weight heparin indicated for preventing blood clots. These additional approvals bring the total of currently authorized biosimilars in Europe to 22 and the product classes to eight as set forth below.
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Pending Biosimilar Applications
In addition to the 22 approved biosimilars, 16 additional biosimilar applications are under evaluation by the EMA as of December 1, 2016: four applications for biosimilars of AbbVie’s (adalimumab), two applications for biosimilars of Amgen’s Enbrel (etanercept), one application for a biosimilar of Sanofi’s Lantus (insulin glargine), one application for a biosimilar of Eli Lilly’s Humalog (insulin lispro), three applications for biosimilars of Amgen’s Neulasta (pegfilgrastim), two applications for biosimilars of Roche’s MabThera/Rituxan (rituximab) and three applications for Genentech’s Herceptin (trastuzumab). 12 of the pending applications seek to introduce biosimilars that fall into new product classes for the European market, i.e., biosimilars of adalimumab, pegfilgrastim, rituximab, and trastuzumab. EMA’s Committee for Medicinal Products for Human Use (CHMP) also recently issued a positive opinion for the first biosimilar, Celltrion’s Truxima, of Roche’s rituximab, a blockbuster monoclonal antibody for treating cancer. Truxima is expected to be approved in early 2017.
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Source: Lexology – Patterson Belknap Webb & Tyler LLPJacob F. Siegel and Irena Royzman