August 11, 2014 I Remsima® is expected to be the first biosimilar monoclonal antibody to be filed through United States of America Food and Drug Administration’s biosimilar regulatory approval pathway, the Biologics Price Competition and Innovation Act of 2009 (BPCIA)

Celltrion announced that the company, on August 8, 2014, completed the filing procedure to obtain US FDA approval for its infliximab biosimilar. This marks the first 351(k) biosimilar mAb application to be filed in the U.S.A. and the second application for a biosimilar to be filed through the US BPCIA.

Sandoz, the generic branch of the multinational pharmaceutical company Novartis, has already filed for application of its filgrastim biosimilar, which is the first and only biosimilar application that has been accepted for US FDA review under the US BPCIA.

After prior consultation with the US FDA, Celltrion conducted additional clinical trials (starting on October 2013 and lasting 6 months) 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®.

A Celltrion official made a statement: “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.”

About Celltrion

Celltrion, Inc. (“Celltrion”) is a global biopharmaceutical company located in Incheon, Republic of Korea. Celltrion’s objectives are to develop and manufacture biosimilar monoclonal antibodies (mAbs) and novel drugs for various therapeutic areas including oncology and autoimmune diseases.

Since its foundation in 2002, Celltrion has built world-class manufacture and research facilities, developed state-of-the-art technologies, and established quality systems through active recruitment of skilled personnel and infusion of capital investment. Celltrion has secured 140,000L mammalian cell culture facilities, which were built in compliance with the EU and US GMP regulations and which are situated in Incheon, Republic of Korea.

SOURCE: Celltrion