A number of biosimilar makers have tried to obtain approval for proposed biosimilar versions of Amgen’s Neulasta (pegfilgrastim), a long-acting version of Amgen’s Neupogen (filgrastim), but have encountered hurdles so far both in the U.S. and Europe.
Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). The EMA has approved four additional biosimilars in 2016, including three biosimilars in two new classes: a biosimilar of Amgen’s Enbrel (etanercept) and two biosimilars of Sanofi’s Clexane (enoxaparin sodium). In addition to the now 22 approved biosimilars, 16 additional biosimilar applications are under evaluation by the EMA with 12 of the 16 falling in four new product classes: biosimilars of Amgen’s Neulasta (pegfilgrastim), Genentech’s Herceptin (trastuzumab), Roche’s MabThera (rituximab) and AbbVie’s Humira (adalimumab). While Europe’s biosimilar pathway offers important lessons for the U.S., the Food and Drug Administration (FDA) is setting its own path. Two of the four biosimilars approved in the U.S., Sandoz’s biosimilar of Amgen’s Enbrel and Amgen’s biosimilar of AbbVie’s Humira, were approved in the U.S. without any prior approval in Europe. The FDA has also rejected applications for proposed biosimilars with authorization and marketing experience in Europe, making clear that approval in Europe will not necessarily result in approval in the U.S.
On August 30 FDA approved Sandoz Inc.’s biosimilar of Enbrel (etanercept), Amgen Inc.’s blockbuster biologic for treatment of moderate to severe rheumatoid arthritis and a number of other autoimmune conditions. The biosimilar, Erelzi (etanercept-szzs), is the third biosimilar approved for marketing in the US under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Erelzi has been approved for all of Enbrel’s indications and is the first U.S. biosimilar of etanercept.
On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Samsung Bioepis’s Benepali, the first biosimilar of Enbrel (etanercept), in Europe. Enbrel is a blockbuster treatment for rheumatoid arthritis and a number of other autoimmune conditions associated with elevated levels of tumor necrosis factor alpha (TNF-alpha), a protein that plays an important role in promoting inflammation. The CHMP recommended approval of Benepali for these conditions. In the US, FDA recently accepted Sandoz’s regulatory application for its proposed biosimilar of Enbrel for review. Sandoz is seeking approval for all of Enbrel’s indications. FDA’s review of Sandoz’s proposed biosimilar will provide important information on the requirements for biosimilarity and extrapolation for complex biologic products.