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FDA withdraws biosimilar statistical guidance Posted 06/07/2018

The US Food and Drug Administration (FDA) announced on 21 June 2018 that it had withdrawn the draft guidance on analytical studies of biosimilars. The agency does, however, plan to issue an amended version that ‘will reflect state-of-the-art techniques in the evaluation of analytical data’ and give sponsors ‘appropriate flexibility’.

The agency released the draft guidance for public comment in September 2017 saying that it would, when finalized, provide advice on the evaluation of analytical similarity for biosimilars [1].

Statistical approaches to evaluate analytical similarity – Guidance for industry
Date: September 2017

The draft outlined the type of information sponsors should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan and the statistical approaches recommended for evaluating analytical similarity.

The agency received 17 comments from stakeholders, which included pharma companies, such as Amgen, Boehringer Ingelheim, Genentech and Pfizer, as well as physician associations, e.g. the Hematology/Oncology Pharmacy Association (HOPA), and industry groups, such as the Association for Accessible Medicines (AAM) and its Biosimilars Council [2].

FDA now says that ‘after considering public comments that the agency received about the draft guidance, FDA determined it would withdraw the draft guidance as it gives further consideration to the scientific and regulatory issues involved’. It added that ‘comments submitted to the docket addressed a range of issues that could impact the cost and efficiency of biosimilar development’. Issues highlighted included the number of lots of reference products to be sampled. The agency called for a minimum of 10 reference product lots and recommended alternative assessments in cases where access to the reference product is limited.

Stakeholders also criticized the specific statistical methods proposed by the guidance for determining analytical similarity and the requirement that lots come from US-sourced reference products.

FDA did not say when a new draft guidance document would be available, but said that it ‘will communicate publicly when new draft guidance is issued in relation to the evaluation of analytical data between a proposed biosimilar product and a reference product’.

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1.  GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on statistical approaches to evaluating similarity for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-statistical-approaches-to-evaluating-similarity-for-biosimilars
2.  GaBI Online - Generics and Biosimilars Initiative. Stakeholders comment on FDA’s draft statistical biosimilarity guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. Available from: www.gabionline.net/Guidelines/Stakeholders-comment-on-FDA-s-draft-statistical-biosimilarity-guidance

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Source: US FDA

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