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US FDA Moves To Codify Size-Based Threshold For Drugs To Be Deemed Biologics

 
• By Bowman Cox

Agency proposes to define by regulation which proteins previously approved as drugs will be deemed licensed biologics, and therefore potentially subject to biosimilars competition. Industry has opposed the size-based thresholds, preferring a structure-based approach.

Insulin Monomer
Insulin, one of the drugs FDA will deem a biologic

Despite industry opposition, the US FDA has resolved to codify the size-based approach it first proposed in February 2012 for determining which approved drugs should be deemed licensed biologics under the law that created the biosimilars pathway.

Once they’re deemed licensed biologics, proteins like insulin that FDA for historical reasons approved as drugs and that have benefited by their complex nature from generic competition will eventually become subject to biosimilars competition, which could drive down prices

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