Insulin Maker Lilly Seeks US FDA Assurances On ‘Authorized Biologics’

 
• By Sue Sutter
  
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Sponsor of an NDA-approved protein product subject to March 2020 ‘transition provisions’ should be able to seek biosimilar licensure of that same product without surrendering its ‘deemed’ 351(a) approval, company says, also requesting that FDA clarify parameters for ‘branded biosimilars.’

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With an eye apparently toward marketing “authorized” biosimilars of its own branded insulins – and possibly an interchangeable version of a competing product – Eli Lilly & Co. is seeking assurance from the US FDA that sponsors of protein products that transition from drugs to biologics in March 2020 will be able to secure approval of biosimilar versions of those same products.

In comments on FDA’s draft Q&A guidance on the Biologics Price Competition and Innovation Act’s "transition provisions," Lilly says...

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