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Allergan, Amgen submit application for possible Avastin biosimilar
THOUSAND OAKS, Calif. — Amgen and Allergan on Wednesday announced their submission of a biologics license application to the Food and Drug Administration for ABP 215, a potential biosimilar of Avastin (bevacizumab). The companies said ABP 215 is the most advanced of the four oncologic biosimilars they are developing, and they believe it’s the first submission for an Avastin biosimilar.FDA primes industry for GDUFA II fee structure changes
In the nearly five years since the Generic Drug User Fee Agreement was enacted under the Food and Drug Administration Safety and Innovation Act of 2012, through the FDA’s Office of Generic Drug, GDUFA has generated some $1.5 billion in user fees and has seen 1,992 approvals issued.
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