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FDA Backs New Biosimilar for Remicade

Infliximab (sold as Remicade in the US) is a biologic used for treating plaque psoriasis and psoriatic arthritis, among other indications. Remicade’s cost has soared in recent years and it is hoped that approving a biosimilar will provide patients with a lower cost drug. Biosimilars are highly similar to an already FDA-approved biological product and have been shown to have no clinically meaningful differences from the reference product.

The FDA has given its backing to a biosimilar, CT-P13 for all but one of the same indications for which Remicade is currently used. CT-P13, manufactured by South Korea-based Celltrion, is currently approved in 67 countries. The majority of a FDA panel agreed that CT-P13 is “highly-similar” to Remicade for most of the clinical indications. The CT-P13 infliximab formulation is identical to that of its reference product (Remicade) and it has similar physiochemical characteristics.

At a public hearing, clinicians and panel members expressed concerns that approving CT-P13 could cause the drug being substituted for Remicade without a patient’s or physician’s knowledge. The FDA hoped to assuage those fears by stating that “if approved, CT-P13 would be indicated for treatment-naive patients or for a one-time switch from Remicade…. CT-P13 would not be considered interchangeable with Remicade.”  Other concerns addressed at the hearing included the fact Celltrion’s trials for CT-P13 were only conducted with patients with rheumatoid arthritis and patients with ankylosing spondylitis. Nevertheless, the panel stated that they were convinced that Celltrion had proven that CT-P13 was similar for most indications.

Byline: Martha L. Sikes, MS, RPh, PA-C

Posted: March 15, 2016

Source: Medscape Medical NewsAdapted from the original article.

[Image: WikimediaImages]




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