21 July 2016Americas

Sandoz Neulasta biosimilar rejected by FDA

The US Food and Drug Administration (FDA) has given Sandoz a complete response to its Neulasta (pegfilgrastimcandidate) biosimilar application, in which the application was rejected.

Novartis, the parent company of Sandoz, said in statement accompanying its recently published financial results: “Sandoz received a comp lete response letter from the FDA for biosimilar pegfilgrastim candidate (Neulasta).

“We are working with the agency to address remaining questions.”

Sandoz filed its application for its biosimilar version of Neulasta in November last year.

The original producer of the drug, called Neutropenia, is Amgen.

Under FDA rules, biosimilar applicants that are unsuccessful are sent a complete response letter to indicate that the review cycle for an application is complete but that it is not ready for approval.

Novartis was the first company to get approval for a biosimilar in the US in 2005 when the FDA cleared Zarxio, a biosimilar of Amgen’s Neupogen.

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