FDA extends comment period for interchangeability guidance

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FDA extends comment period for interchangeability guidance

Home/Guidelines | Posted 24/03/2017 0 Post your comment

In a Federal Register notice published on 15 March 2017 the US Food and Drug Administration (FDA) announced that it would be extending the comment period on its draft guidance on the interchangeability of biosimilars with their reference biologicals. This change came after the agency received requests for an extension.

FDA finally issued its much anticipated guidance on the interchangeability of biosimilars on 18 January 2017. In it FDA outlines its requirements for biosimilar makers looking to prove that their versions are interchangeable with the originator biologicals [1].

The draft guidance made it clear that biosimilars makers will first have to prove that their product is ‘biosimilar’ to the reference biological. Then, in order to claim ‘interchangeability’ for the biosimilar, submit additional information to show that it ‘can be expected to produce the same clinical result as the reference product in any given patient’ and that there are no additional safety risks associated with switching. In fact, to prove interchangeability, the bar seems to have been set rather high for biosimilars, with multiple switches being required.

Industry groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) requested the extension in order to review the scientific and regulatory recommendations in the draft guidance.

FDA had originally released the draft on 18 January 2017 for a comment period of 60 days, i.e. until 20 March 2017, but has now extended that period to 19 May 2017. Comments on the draft guidance can be posted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. This can be done via the website www.regulations.gov or written comments can be mailed to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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 FDA issues draft guidance on biosimilar interchangeability [www.gabionline.net].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 2017 Mar 24]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-biosimilar-interchangeability

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Source: Federal Register