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US Interchangeability ‘Irrelevant’ And ‘Makes No Sense’ Says Sandoz

CEO And North America Head Discuss Evolving FDA Approach To Biosimilars

 
• By Dave Wallace

At the recent Morgan Stanley Healthcare Conference in New York, Sandoz leaders set out their views on the significance of – and the FDA’s initial implementation of – the US biosimilar interchangeability designation.

Syringe and vial with question mark
The FDA’s initial approach to interchangeability “makes no sense whatsoever” to Sandoz CEO Richard Saynor • Source: Shutterstock

“The way the FDA has originally characterized interchangeability, to me, makes no sense whatsoever.” That was the blunt assessment of Sandoz CEO Richard Saynor as he was asked about biosimilar interchangeability in the US at the recent Morgan Stanley Healthcare Conference in New York in early September.

Asked how Sandoz was thinking about biosimilar interchangeability going forward, in a context in which requirements to qualify for the designation are evolving and mentions of interchangeability are being removed from biosimilar labels (Also see "FDA Heralds The End Of Switching Studies For Biosimilar Interchangeability" - Generics Bulletin, 20 June, 2024

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