Wednesday, August 8, 2012

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 13th 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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1 comment :

Michael Lorton said...

Dear Dr. Belton: Thank you for the post. The U.S. FDA posts on-line all pharmacology, clinical, statistical, and CMC (chemistry, manufacturing, and control) review data immediately upon approval of a biologic (e.g. mAb). Would you be so good as to point me to the URL for the Korean FDA release of that type of data for Remsima (follow-on infliximab)? I would be particularly interested in the pharmacology data (i.e. the high performance liquid chromatography graphs comparing the species of Remsima with reference Remicade under identical gradient elution protocols), and the statistical data from the clinical trials that were used to extrapolate the data to approval for almost all of the Remicade clinical indications. I would also be interest in finding the basis for your "20-40% decrease in cost" assertion. Thanks. Michael D. Lorton, M.D.

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