FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Approves Third Remicade Biosimilar

Dec. 18, 2017
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The FDA approved Pfizer’s drug Ifixi for multiple indications.

The drug, the third biosimilar for Remicade, is approved for treatment of Crohn’s Disease, ulcerative colitis, and psoriatic and rheumatoid arthritis. It is intended for intravenous use.

Potential side effects of the biosimilar include serious infections including tuberculosis, and TB testing is recommended before starting the drug, the FDA said.

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