Insulin Application Reviews Would Continue After March 2020 Under Senate Bill
Bill would change US FDA's approach to handling follow-on applications submitted under Section 505 once products become "deemed" as biologics 23 March 2020, and could amend a provision in the Senate HELP Committee's health care bill, which aligns with FDA policy.
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Thirty-month stay resulting from Sanofi’s patent lawsuit expires on 18 March 2020, two days before Mylan’s application must receive final approval to avoid getting caught in the transition of insulins from drug to biologic regulation. Pre-approval inspection of Biocon’s manufacturing facility resulted in 12 ‘largely procedural’ observations, company says.
Discussion draft includes provision requiring completion of assessments of transitioning NDA applications filed by 23 September, even if review lasts beyond the official 2020 transition date.
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.