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Biosimilar Version of Remicade for Autoimmune Diseases Likely to Get FDA Approval

by Reshma Anand on February 10, 2016 at 4:17 PM
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Biosimilar Version of Remicade for Autoimmune Diseases Likely to Get FDA Approval

Remsima could soon become the second biosimilar drug to be approved by the U.S. Food and Drug Administration.

Biosimilar drugs are drugs made from living cells and are relatively cheaper than generic medicines. They function similar to its generic drug and helps to cure ailments.


Remsima is a biosimilar drug of Johnson & Johnson's Remicade. Remicade helps in the treatment of rheumatoid arthritis, Crohn's disease and ulcerative colitis.

Remsima has been developed by South Korea's Celltrion and co-marketed with Pfizer. The drug was tested for arthritis and trials against bowel diseases are being conducted by the company.

Now the FDA panel has voted 21-3 for the biosimilar drug, supporting its approval on April 6. There are objections from the J&J company due to its on-going trials against bowel diseases.

The statement from J&J reads that, "We believe that the data to date, absent of direct comparisons of CT-P13 and REMICADE in patients with inflammatory bowel disease, leave uncertainty about whether differences in safety or efficacy may emerge for patients," said Jay Siegel, M.D., Chief Biotechnology Officer and Head, Scientific Strategy and Policy at Johnson & Johnson.

"We appreciate the discussions at today's hearing, and note that some of the advisors—who voted on either side of the question—share our concerns regarding residual uncertainty about the use of CT-P13 in IBD. We hope that FDA carefully considers our detailed written testimony," he added.

But the FDA has recommended the biosimilar drug to be approved for treating autoimmune diseases similar to that of the drug Remicade. The drug will be priced lesser to that of its original drug.

The first biosimilar drug approved by the FDA was Zarzio. It is a version of Amgen's Neupogen, which boosts white blood cells in patients who have undergone chemotherapy.

Source: Medindia

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