Celltrion announces Korean approval of biosimilar monoclonal antibody

On July 23, 2012, Celltrion announced the approval by the Korean Food and Drug Administration of REMSIMA, its biosimilar anti-TNFα monoclonal antibody. REMSIMA, previously known as CT-P13, is a biosimilar version of Johnson & Johnson’s infliximab product, REMICADE.

Celltrion had previously announced results of a phase I clinical trial in around 250 patients with ankylosing spondylitis and a phase III clinical trial in around 580 patients with rheumatoid arthritis. The PLANET clinical studies demonstrated the equivalence of CT-P13 and infliximab in pharmacokinetics, safety and efficacy. According to the press release, Celltrion has invested approximately  $200 Million USD in developing CT-P13 through the end of clinical trials. A copy of Celltrion’s release announcing the  PLANET clinical trial results may be found here.

Celltrion has also submitted a regulatory application to the European Medicines Agency for CT-P13.

Celltrion’s announcement (in Korean) may be found here. Other English language sources reporting the  approval may be found here, here and here.