FDA rolls out expectations for a looming regulatory shift for insulin and other biologics
Certain biologics will be removed from the FDA’s Orange Book on 23 March 2020 and included in the Purple Book, and all subsequent follow-on applicants will not be able to rely upon these new drug applications for approval but will have to win approval as biosimilars under new proposed rules on biosimilar development.
The agency on Tuesday released two new draft Q&A guidance documents on biosimilar development and the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as well as two final guidance documents on the same topics and one proposed rule amending the definition of a biological product.
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