Celltrion Files For FDA Approval For Biosimilar Drug

Celltrion predicts that it is one year away from approval for Remsima®, a biosimilar based on an originator drug from Janssen Biotech.

AsianScientist (Aug. 19, 2014) – Celltrion, a biopharmaceutical company based in Korea, has completed filing for United States Food and Drug Administration (FDA) approval for its biosimilar monoclonal antibody Remsima®. Remsima® is a TNF-α antagonist used for the treatment of autoimmune conditions such as rheumatoid arthritis and ankylosing spondylitis.

After prior consultation with the US FDA, Celltrion conducted additional clinical trials to determine the bioequivalency of the originator products with Remsima®. Specifically, Celltrion tested for pharmacokinetic/pharmacodynamic (PK/PD) equivalency and safety equivalency for the three distinct products, the originator products sold in the US, the originator products sold in Europe, and Remsima®. These additional clinical trial data, along with Celltrion’s established global clinical trial data, were submitted to the US FDA by Celltrion as part of its application.

Barring any setbacks, Celltrion anticipates obtaining US FDA approval within one year. The patent for the originator drug is set to expire at the end of 2018 however, in support of its US FDA application, Celltrion has currently 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.

Celltrion has already obtained approval for its biosimilar infliximab product, which uses the registered brand name of Remsima®, from over 50 countries worldwide, including most of advanced regulatory agencies including Europe, Canada and Japan. In fact, Remsima® remains the world’s first and only biosimilar mAb to be approved by the European EMA, Japan PMDA, and Health Canada. This US FDA filing will mark the final step for Celltrion’s goal of obtaining global approval for Remsima®.

“Our US biosimilar BLA application is garnering interest not only from other biosimilar developers, but from healthcare providers and the healthcare industry as a whole. This is because the medical community is aware that the eventual approval of sales of biosimilars in the US market will signal an age where biosimilar mAbs are globally recognized as innovative high quality biologics, with equivalency in both efficacy and safety to their originator products, available to patients in need at a more affordable price,” a Celltrion representative said.

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Source: Celltrion.
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