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Enbrel Biosimilar Approved in US But Enjoined For Now

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.  In its announcement FDA noted that “Erelzi has been approved as a biosimilar [to Enbrel], not as an interchangeable product.”  FDA initially accepted Sandoz’s biosimilar application last October.  The European Medicines Agency (EMA) also accepted Sandoz’s application for review last year.  EMA has already approved another etanercept biosimilar, Biogen and Samsung Bioepis’s Benepali, for marketing in Europe.

Meanwhile, Sandoz is barred from marketing its biosimilar in the U.S. for now.  Sandoz stipulated to an injunction that Judge Cecchi in the District of New Jersey ordered on August 11, 2016, without the need for any bond to be posted.  The injunction provides that Sandoz will not “make, use, import, offer to sell, or sell” Erelzi, but the terms of the stipulation have been sealed by the court. There is no question, however, that under the Federal Circuit’s recent decision in Amgen v. Apotex, No. 2016-1308 (Fed, Cir. July 5, 2016), Sandoz cannot launch its product at least until after 180 days’ post-licensure notice of first commercial marketing.  In the pending litigation, filed by Amgen with Hoffman-La Roche and Immunex in February 2016, Amgen asserts that Sandoz infringes five patents protecting Enbrel.  Plaintiffs sued after Sandoz allegedly cut short the BPCIA’s patent dispute resolution procedures triggered by the acceptance of its regulatory application for review.  The case is set for trial on April 17, 2018.

Of note, the nonproprietary name of Sandoz’s biosimilar, etanercept-szzs, appears to follow FDA’s recent draft guidance for nonproprietary naming of innovator biologics and biosimilars.  The draft guidance recommends that nonproprietary names for biologic products should consist of the “core” nonproprietary name of the product plus a unique four-letter suffix. Under the draft guidance, innovator biologics and biosimilar versions of them will have the same “core” names but different suffixes, and therefore distinct nonproprietary names.

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