South Korea’s Celltrion Files for FDA Approval for Biosimilar Monoclonal Antibody Infliximab
Celltrion, a biopharmaceutical company based in Incheon, South Korea, has filed with the US Food and Drug Administration (FDA) for marketing approval for Remsima, a biosimilar of the monoclonal antibody infliximab, the active ingredient in Janssen Biotech’s Remicade, a drug to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, plaque psoriasis, and ulcerative colitis.
Celltrion says it expects that Remsima will be the first biosimilar monoclonal antibody to be filed through the US FDA’s biosimilar regulatory approval pathway under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Celltrion completed the filing procedure to obtain US FDA approval for its infliximab biosimilar on August 8, 2014. The company says that the filing marks the first 351(k) biosimilar mAb application to be filed in the US, and the second application for a biosimilar to be filed through the US BPCIA. Sandoz, the generics arm of Novartis, filed for application of its filgrastim biosimilar, whichwas accepted for US FDA review under the US BPCIA.
In filing for US FDA approval, Celltrion said it consulted with the US FDA and conducted additional clinical trials (starting on October 2013 and lasting six months) to determine the bioequivalency of the originator products with Remsima. Specifically, Celltrion tested for pharmacokinetic/pharmacodynamic 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 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 says it 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.
Celltrion has obtained approval for its biosimilar infliximab product, which uses the registered brand name of Remsima, from over 50 countries worldwide, including in Europe, Canada, and Japan.
Celltrion's strategic focus is to develop and manufacture biosimilar monoclonal antibodies and novel drugs for various therapeutic areas, including oncology and autoimmune diseases. The company has 140,000 L of mammalian cell culture capacity in its facilities in Incheon.
See related story, “FDA Accepts BLA for Sandoz’s Biosimilar of Filgrastim.”