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First Biosimilar Monoclonal Antibody (Remsima) Submitted for FDA Review

Approval decision due next year

Remsima is expected to be the first biosimilar monoclonal antibody (mAb) to be filed through the FDA’s biosimilar regulatory approval pathway: the Biologics Price Competition and Innovation Act (BPCIA) of 2009.

The product’s developer (Celltrion) has announced that it completed the filing procedure on August 8. This marks the first 351(k) biosimilar mAb application to be filed in the U.S. and the second application for a biosimilar to be filed through the BPCIA. Sandoz, the generic branch of Novartis, previously filed for application of a filgrastim biosimilar.

After consultation with the FDA, Celltrion conducted additional clinical trials (starting on October 2013 and lasting 6 months) to determine the bioequivalency of originator products versus Remsima. Specifically, Celltrion tested the pharmacokinetic/pharmacodynamic equivalency and safety equivalency for three distinct products: the originator products sold in the U.S., the originator products sold in Europe, and Remsima. These additional clinical trial data, along with established global clinical data, were submitted to the FDA by Celltrion as part of its application.

Barring any setbacks, the FDA is expected to reach an approval decision within 1 year.

The patent for the originator drug is set to expire at the end of 2018; however, in support of its FDA application, Celltrion has filed a lawsuit in the federal court of Massachusetts seeking a declaratory judgment that Janssen Biotech’s remaining patents on the original reference drug (Remicade [infliximab]) are invalid and unenforceable.

Source: PipelineReview; August 13, 2014.

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