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Insulin Biosimilars: US FDA Hears Wide Range Of Views From Small Set Of Sponsors

 
• By Michael McCaughan

US FDA heard a predictably wide range of advice on the appropriate standards for approving biosimilar and interchangeable insulin during a public hearing on the topic. What is surprising is how few sponsors decided to speak out.

Seating-conference

The most noteworthy aspect of the US Food & Drug Administration’s 13 May hearing on the pathway for biosimilar insulin may have been the very limited number of sponsors who chose to present.

Of the three largest suppliers of insulin in the US, only Eli Lilly & Co. made a formal statement during the “Part 15” hearing; Novo Nordisk AS and Sanofi US did not make remarks. Given the overarching political interest in insulin pricing – and the broader themes in

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More from Biosimilars & Generics

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