Biosimilars interchangeability guidance expected by end 2017

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Biosimilars interchangeability guidance expected by end 2017

INICIO/Directrices | Posted 14/10/2016 0 Post your comment

The US Food and Drug Administration (FDA) is not likely to produce draft guidance on interchangeability of biosimilars before the end of 2017.

The revelation came as part of the agency’s commitments in its Biosimilar User Fee Act II (BsUFA II) performance goals letter [1]. The letter outlines the agency’s goals and procedures during fiscal years 2018 through 2022.

The FDA’s BsUFA II commitment letter, which was released on 16 September 2016, states that the agency will publish draft guidance describing considerations for designating biosimilars as interchangeable to a reference product on or before 31 December 2017. The final guidance, which is expected to clarify FDA’s stance on first establishing biosimilarity followed by interchangeability [2], will then only be available on or before 31 May 2019.

These timelines also apply to the draft guidance for ‘Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity’ [3]. While a draft guidance document describing processes and further considerations related to post-approval manufacturing changes for biosimilars is expected on or before 31 March 2019.

The agency also intends to finalize three of its existing draft guidances:
• Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (draft guidance published in May 2014)
• Nonproprietary Naming of Biological Products (draft guidance published in August 2015)
• Labeling for Biosimilar Biological Products (draft guidance published in March 2016)

These guidance documents are expected to be finalized on or before 31 May 2019.

Related article
US guidelines for biosimilars

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar User Fee Act reauthorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilar-User-Fee-Act-reauthorization
2. Derbyshire M. Demonstrating interchangeability and biosimilarity for US biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(3):139. doi:10.5639/gabij.2016.0503.035
3. GaBI Online - Generics and Biosimilars Initiative. FDA on interchangeability and demonstrating biosimilarity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 14]. Available from: www.gabionline.net/Guidelines/FDA-on-interchangeability-and-demonstrating-biosimilarity

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Source: US FDA