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BRIEF-Alvotech Says FDA Defers Action on Application For Proposed Humira Biosimilar
REUTERS 10:28 AM ET 9/20/2021
Sept 20 (Reuters) - Alvotech:
* ALVOTECH PROVIDES UPDATE ON FDA ACTION REGARDING AVT02, PROPOSED HIGH-CONCENTRATION BIOSIMILAR TO HUMIRA® (ADALIMUMAB)
* ALVOTECH: FDA DEFERRING ACTION ON APPLICATION FOR AVT02, PROPOSED BIOSIMILAR TO HUMIRA, UNTIL FACILITY ASSESSMENTS CAN BE COMPLETED
* ALVOTECH: CONTINUES TO WORK WITH FDA TO COORDINATE REQUIRED INSPECTION(S) IN SAFE AND ADEQUATE MANNER Source text for Eikon: Further