Lack of confidence in biosimilars slowing uptake in the US

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Lack of confidence is amongst the various obstacles causing slow uptake of biosimilars in the US.


Many current US Food and Drug Administration (FDA) approved biosimilars treat chronic conditions, where a patient tends to stay on one drug and switch only when that treatment stops working or the patient experiences unwanted side effects. This makes patients and providers resistant to switching to biosimilars. This clinical barrier could be reduced if biosimilars were to achieve interchangeability status, a designation level above basic biosimilarity status, which would make it easier for payers and pharmacies to encourage switching and even implement automatic substitution.

FDA finally issued its much anticipated guidance on the interchangeability of biosimilars with their reference biologicals in January 2017 [1]. According to these draft guidelines, costly and time-consuming switching studies are required. To date, only Boehringer Ingelheim has announced that it has started an interchangeability trial for its adalimumab biosimilar [2].

Without interchangeability, payers will likely allow patients to remain on the originator product, even if they do pursue formulary policies to prefer biosimilars for new start patients.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilar interchangeability []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim starts phase III interchangeability trial for adalimumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from:

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Source: Trinity Partners

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