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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 • Source: Alamy

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.

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