Novartis' FDA-approved biosimilar launch delayed over patent dispute with Amgen

Although Novartis earned approval from the Food and Drug Administration for its biosimilar drug Erelzi, the Swiss drugmaker said it will not hit the market before 2018 due to a patent dispute with Thousand Oaks, Calif.-based Amgen, reports Reuters.

Erelzi is a copy of Amgen's best-selling psoriasis drug Enbrel. Amgen filed a lawsuit against Novartis, claiming it has patent protection on Enbrel until 2029.

Richard Francis, head of Novartis' generic drug unit Sandoz, said it will take at least another year to resolve the legal battle, according to the report.

"That won't really reach a conclusion until 2018," Mr. Francis told Reuters. "That's the frustration sometimes of the legal situation, but the way I look at that, we're carving the landscape out as we go."

Novartis and Amgen are also involved in a separate lawsuit on whether drug companies must wait six months after winning regulatory approval before selling biosimilars.

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