Sandoz starts clinical trial of Enbrel biosimilar

Drug maker hopes to win approval for biosimilar etanercept in the U.S., E.U.

HOLZKIRCHEN, Germany — Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.

Sandoz, the generics arm of Swiss drug maker Novartis, said it had started a phase-3 trial of biosimilar etanercept, a knock-off version of Amgen's Enbrel, used to treat chronic plaque-type psoriasis.

"Sandoz has a strong track record in developing and commercializing biosimilars around the world," Sandoz head of biopharmaceuticals and oncology injectables Ameet Mallik said. "We will leverage this experience and our industry-leading capabilities to bring a biosimilar version of etanercept to patients and physicians around the world."

Sandoz has made biosimilars for the European market for several years, alongside competitors Teva Pharmaceutical Industries and Hospira. In the United States, the Patient Protection and Affordable Care Act of 2010 included amendments to create an abbreviated regulatory approval pathway for biosimilars, but the Food and Drug Administration has yet to finish drafting regulations, and will likely be a few years before biosimilars approved under the abbreviated pathway become available. In the meantime, several companies have sought approval for biosimilars using the normal three-phase clinical trial process and approval pathway in place for novel biotech drugs, and it is expected that the abbreviated pathway will include clinical trial requirements as well.

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