Celltrion Gains Approval for Remicade Biosimilar

Today's guest post is authored by Amy M. Belton, PhD, Research Associate, Johns Hopkins University School of Medicine.

A leading Korean biopharmaceutical company, Celltrion, recently announced their successful approval by the Korean Food and Drug Administration (KFDA) to develop the biosimilar monoclonal antibody Remsima.  The biosimilar “Remsima” is a version of the blockbuster drug Remicade (inflixamab) by Johnson and Johnson.  Remsima was approved under the global biosimilars guidelines making it the world first true biosimilar antibody.  Remsima has been approved by the KFDA for the treatment of rheumatoid arthritis, ulcerative colitis (UC), Crohn’s disease, ankylosing spondylitis and psoriasis.

The cost of treatment with Remicade can range from $19000-$22000 a year per patient. These costs are usually covered by major medical insurance. The biosimilar Remsima could offer a 20-40% decrease in cost for the payor and patient. This offers significant decreases in the costs associated with treatment. Celltrion started as a contract manufacturing organization and is now entering into agreements with companies such as Hospira to develop biosimilars for other blockbuster drugs.

At next month's 13^th Annual Biosimilars and Generic Drugs meeting in Boston, MA participants will be able to get insight from ShinJae Chang, VP, R&D Celltrion into the strategies used to develop and market biosimilars globally.  For more on this session, download the agenda.  If you'd like to join me in Boston, register today and mention code XP1786BLOG to save 15% off the standard rate!

Do you think Celltrion will be able to successfully market Remsima globally (US, EU markets)? If not, what do you think will be some of their roadblocks? Do you think they are now the global leader in biosimilar development?

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