FDA issues another biosimilars Q&A guidance

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On 13 May 2015, the US Food and Drug Administration (FDA) issued another question and answer guidance document for biosimilar applications in the US. The draft guidance contains a question on the issue of interchangeability with reference biologicals.

Guidance V13F21

FDA also recently finalized three other guidelines in April 2015 [1]. FDA first published the three draft guidelines in February 2012 [2], following the signing into law of the biosimilars pathway as part of the Biologics Price Competition and Innovation Act (BPCI) in 2010.

The agency has now issued a draft guidance on additional questions and answers on biosimilars. The guidance provides new and revised questions and answers. It also includes certain original questions and answers that have not yet been finalized.

Biosimilars: additional questions and answers regarding implementation of the Biologics Prices Competition and Innovation Act of 2009
Date: May 2015

One of the new questions concerns demonstration of interchangeability, which FDA says will be possible to determine in an original biosimilar application. Although, rather disappointingly, the agency also states that ‘at this time, it would be difficult as a scientific matter for a prospective biosimilar applicant to establish interchangeability in an original 351(k) application given the statutory standard for interchangeability and the sequential nature of that assessment.’ FDA says that it ‘is continuing to consider the type of information sufficient to enable FDA to determine that a biological product is interchangeable with the reference product.’

The draft guidance document is being distributed for comment.

What happens next?
Comments and suggestions regarding this notice can be submitted to www.regulations.gov or to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, USA, within 60 days of publication (13 May 2015) in the Federal Register of the notice announcing the availability of the draft guidance. That means that all comments and suggestions should be submitted by 12 July 2015.

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Interchangeability not covered in FDA draft biosimilar guidance

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1.   GaBI Online - Generics and Biosimilars Initiative. FDA finalizes biosimilars guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 22]. Available from: www.gabionline.net/Guidelines/FDA-finalizes-biosimilars-guidelines 
2.   GaBI Online - Generics and Biosimilars Initiative. FDA finally issues draft biosimilar guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 22]. Available from: www.gabionline.net/Guidelines/FDA-finally-issues-draft-biosimilar-guidance 

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Source: Federal Register, FDA

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