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Sandoz’s High-Concentration Humira Biosimilar Lands On FDA’s Desk

SBLA Follows EMA Accepting Proposed Biosimilar For Filing In June

 
• By Dean Rudge

Sandoz has named its three most promising upcoming biosimilar launches, ahead of filing its proposed high-concentration version of adalimumab with the US Food and Drug Administration.

FDA website
Sandoz's filing is now with both the US and EU regulators • Source: Shutterstock

Sandoz has followed swiftly its proposed higher strength biosimilar version of Humira (adalimumab) being accepted for filing by the European Medicines Agency, with a corresponding filing in the US.

The US Food and Drug Administration has accepted for review the company’s supplemental biologics license application for the proposed high concentration formulation,

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