Etanercept Biosimilar Under FDA Review


The FDA has accepted Sandoz's Biologics License Application (BLA) for its proposed etanercept (Enbrel) biosimilar.

The FDA has accepted Sandoz’s Biologics License Application (BLA) for its proposed etanercept (Enbrel) biosimilar.

Sandoz believes it is the first to receive BLA acceptance for a biosimilar to Amgen’s Enbrel, a tumor necrosis factor alpha (TNF-alpha) inhibitor.

The company is seeking approval for all indications included in the label of the biosimilar, which can treat a range of autoimmune diseases such as rheumatoid arthritis and psoriasis.

“Anti-TNFs will continue to play a leading role in immunology treatment, and the acceptance of our regulatory submission by the FDA today is a significant step toward increasing patient access to these life-changing medicines,” said Mark McCamish, head of Sandoz’s Global Pharmaceutical and Oncology Injectables Development, in a press release.

Common adverse effects of Embrel include pain at the injection site, upper respiratory infections, and headache, while more severe adverse effects include blood problems, nervous system issues, and infections.

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