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.

Related articles
Legal and promotional wars being waged against biosimilars

Biosimilars pricing slowing uptake in the US

Obstacles to biosimilars uptake in the US

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 FDA issues draft guidance on biosimilar interchangeability [www.gabionline.net].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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.