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US FDA's Gottlieb Shuts The Door On Exclusivity For 'Transition' Biologics

Executive Summary

With an eye toward interchangeable insulins, FDA commissioner says existing protein products that will be 'deemed to be licensed' as biologics in March 2020 will not gain any additional exclusivity; coupled with the loss of existing unexpired exclusivity, the decision may spur innovator lawsuits against the agency for an unconstitutional 'taking.'

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Countdown To Transition: US FDA Says 91 Drugs Will Become Biologics In March 2020

A Pink Sheet infographic shows how insulins account for the largest category of transition products, with 27 NDAs that will be "deemed" BLAs in six months; agency is working on a policy to address the transition of authorized generic insulins to regulation under the PHS Act, Office of Therapeutic Biologics And Biosimilars acting policy director Eva Temkin says.

Best Pathway To Interchangeable Insulins Is In The Eye Of The Beholder

Approaches suggested at a US FDA public hearing include allowing follow-on insulins to take a direct route to interchangeability without first having to be approved as biosimilars, and automatically declaring biosimilar insulins interchangeable with one or more reference products.

Insulin Applications Intended For Biosimilar Pathway May Already Be At US FDA

In congressional testimony, outgoing Commissioner Scott Gottlieb says FDA already has "a lot of applications in-house" and robust interest when asked about the 2020 transition of insulin from regulation as a drug to a biologic.

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