FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Celltrion Expands Remicade Biosimilar to 12 New European Countries

March 3, 2015
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South Korea-based Celltrion launched its biosimilar of Janssen’s autoimmune disease therapy Remicade in another 12 European markets, bringing the product’s total presence to 31 countries.

This news comes less than a month before an FDA advisory committee is due to review Celltrion’s application for a biosimilar of Remicade (infliximab). The company’s therapy will become just the second biosimilar to be considered by an FDA advisory committee at a March 17 meeting.

Celltrion’s version of Remicade (infliximab) debuted today in Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden and the United Kingdom, the pharmaceutical company said. Celltrion markets the therapy under the brand name Remsima.

The monoclonal antibody biosimilar was first approved by the European Medicines Agency in September 2013 as a treatment for rheumatoid arthritis. Its current indications also include Crohn’s disease, ulcerative colitis and psoriasis.

The first panel review ended with a positive recommendation for Sandoz’s biosimilar of Amgen’s Neupogen (filgrastim), largely based on the therapy’s extensive exposure in European markets, but the agency has yet to sign off on any biosimilars in the U.S. Remsima, which has enjoyed far less patient exposure, is one of five applications that have been publicly announced.

Celltrion has partnered with Illinois-based Hospira to market infliximab in the U.S. once approved. The drugmaker already licenses the product from Celltrion in Europe under the brand name Inflectra.

That partnership is not expected to change after Hospira’s pending purchase by Pfizer, as the two companies have promised to work closely on it as the merger progresses. A Celltrion spokesperson saidthat possible succession of the contract will be discussed during that time. — Bryan Koenig