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As a way to rein in the staggering amount of money that Americans spend on the complex drugs known as biologics each year, creating biosimilars as less-expensive alternatives makes sense. Europe has already approved 43 biosimilars; the U.S. just 11 of them. The U.S. will continue to lag behind in the development and use of biosimilars if Congress and the FDA require the “interchangeability” label for pharmacy substitution of reference biologics.

This interchangeability requirement is misguided on several levels, is counterproductive for the adoption of biosimilars, and will force Americans to pay billions of dollars more for these specialty drugs than they need to. The FDA’s role is to regulate drug approvals, not the practice of medicine, which it is veering into with the interchangeability requirement.

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  • Well argued commentary.
    Interchangeability/substitution labeling might be needed to distinguish between Adverse Reactions to originator/biosimilar products.
    However, I am not aware of any reports of immunogenicity related safety issues for any of the biosimilar products approved in the EU, and it is very unlikely that there will be any in the future, considering the long time that the EMA has been monitoring the use of biosimilars in the EU.
    It seems likely to me that the interchangeability classification in the US is just the FDA responding to powerful lobbying by the US biopharma industry….

  • All fair points made in this article. The problem is a “new to market” biosimilar has no market share and a low list price so no PBM would ever substitute it for a more lucrative originator, interchangeable or not. Gov’t insurance could attempt this; but the middleman (PBM) that values higher list price drugs would need to be removed from the equation.

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