Celltrion files for FDA approval for Remicade biosimilar

South Korean biopharmaceutical company Celltrion has applied for approval from the US Food and Drug Administration (FDA) to market a biosimilar version of Remicade (infliximab), it announced yesterday (August 11).

Remicade is a monoclonal antibody (mAb) that is administered intravenously to treat autoimmune diseases including psoriasis, Crohn’s disease and rheumatoid arthritis. Marketed by Janssen, it generated worldwide sales of $6.6 billion in 2013.

According to a statement by Celltrion, the patent for Remicade is not due to expire until the end of 2018. In March, Celltrion filed to invalidate five patents directed to the drug at the US District Court for the District of Massachusetts. The case is still pending.

Celltrion said that it expects Remsima to be the first biosimilar mAb to be filed through the FDA, and the second biosimilar. Last month, Sandoz filed the first biosimilar application with the FDA for approval to make and sell a version of Amgen’s Neupogen (filgrastim).

Celltrion has completed additional clinical trials to determine the bioequivalency of Remicade with Remsima, and said it expects to receive the FDA’s approval of the drug within a year.

Remsima has already received regulatory approval in more than 50 countries, and over the last 12 months has been approved by the European Medicines Agency, Japan’s Pharmaceutical and Medical Devices Agency, and Health Canada.

According to Celltrion, it is the first and only biosimilar mAb to be approved by the regulatory bodies.

In a statement, a Celltrion official said that the company’s application was garnering interest from both biosimilar developers and the healthcare industry “as a whole”:

“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 recognised 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.”