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Biosimilar Interchangeability: A Blessing Or A Curse?

As Industry Awaits First FDA Decision, Views Are Mixed On Interchangeability

 
• By Dave Wallace

Biosimilar interchangeability is a hot topic in the US, with the first FDA decision on a formal interchangeability designation expected this month. But across the industry, views differ dramatically on the desirability and likely impact of this additional standard to biosimilarity.

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Opinions differ across the biosimilars industry on interchangeability

When the US Biologics Price Competition and Innovation Act set out the country’s biosimilars framework in 2009, it contained within it a significant provision that would set the US apart from other markets in its treatment of biosimilarity, in the form of an additional designation for “interchangeable” biosimilars.

Interchangeability is defined by the BPCIA as a separate standard to biosimilarity, and requires a product to not only be...

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