FDA

Biosimilars: New or Déjà Vu?

Estándar

By Jonathan Kay

Arthritis & Rheumatology

Volume 68, Issue 5, pages 1049–1052, May 2016

 

Since the US Food and Drug Administration (FDA) first approved the anti–tumor necrosis factor (anti-TNF) monoclonal antibody infliximab in 1998 to treat patients with inflammatory bowel disease, targeted biologic therapies have revolutionized the treatment of inflammatory diseases. However, their high cost has limited access to these very effective agents for many patients. Thus, biosimilar agents are being developed so that these biopharmaceuticals can be made available at significantly lower prices. CT-P13, a biosimilar infliximab developed in South Korea by Celltrion, was the first biosimilar therapeutic monoclonal antibody approved by a regulatory agency, and it was approved by the US FDA on April 5, 2016. In this issue of Arthritis & Rheumatology, Kim and colleagues report on the use of CT-P13 in South Korea during the first 16 months after its introduction in November 2012 [1].

 

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FDA Warns ‘Don’t Use Tramadol in Children’ & More

Estándar

October 21, 2015 • By

The Rheumatologist

FDA Warning: Don’t Use Tramadol in Children
Tramadol is not FDA approved for treating pain in patients age 17 years and younger.¹ The FDA is investigating the off-label use of tramadol in this patient population because of the rare and serious risks of slowed or difficulty breathing. Tramadol is hepatically converted to the active opioid, O-desmethyltramadol. Fast metabolizers convert the drug more rapidly and completely, leading to higher concentrations of the drug in the blood. This can lead to potentially fatal respiratory side effects.

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