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FDA Dismisses Sandoz’s Biosimilar of Neulasta

July 25, 2016

Sandoz’s application to produce a biosimilar of Amgen’s bone marrow drug Neulasta has been rebuffed by the agency, according to Sandoz’s parent company, Novartis.

The company disclosed that Sandoz received a complete response letter from the agency rejecting the BLA in a second-quarter filing. Sandoz submitted the application back in November, alongside data from three pivotal clinical trials.

It did not disclose the reason for the rejection, which it learned of at the end of June.

News of the rejection comes after the company got a strong recommendation from the agency’s Arthritis Advisory Committee for FDA approval of its biosimilar to Enbrel.

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