FDA issues final guidance on interchangeable biologicals

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FDA issues final guidance on interchangeable biologicals

INICIO/Directrices | Posted 17/05/2019 0 Post your comment

The US Food and Drug Administration (FDA) announced on 10 May 2019 that it had issued final guidance on the pathway for interchangeable biologicals.

The final guidance, according to Acting Commissioner of the US Food and Drug Administration, Norman Sharpless, ‘gives an overview of important scientific considerations in demonstrating interchangeability with a reference product and explains the scientific recommendations for an application or a supplement for a proposed interchangeable product’.

The guidance comes almost a decade after the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an approval pathway for biologicals that are demonstrated to be ‘biosimilar’ to or ‘interchangeable’ with an FDA approved biological brand-name (or reference) product and more than two years after the agency issued its draft guidance [1].

Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry
Date: May 2019
https://www.fda.gov/media/124907/download

The final guidance gives an overview of important scientific considerations in demonstrating interchangeability with a reference product and explains the scientific recommendations for an application or a supplement for a proposed interchangeable product.

No interchangeable biosimilars have to date been approved in the US. Only one company, Boehringer Ingelheim, is known to be actively pursuing interchangeability, having publicly disclosed that it has started an interchangeability study for its proposed adalimumab biosimilar.

Dr Sharpless said that the agency had considered the numerous comments on the draft interchangeability guidance and made changes to provide increased clarity to stakeholders. Changes from the previous draft included removal of the term ‘fingerprint-like’ and use of the term ‘residual uncertainty’ reduced from 20 to a single use. The final guidance also now allows for the comparison of a proposed interchangeable product with a non-US-licensed comparator product.

FDA issues final guidance on bioanalytical method validation

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilar interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 17]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-biosimilar-interchangeability

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Source: Federal Register, US FDA