FDA announced on 6 June 2016 that it was extending the comment period on its proposed guidance for biosimilar labelling by an additional 60 days. However, despite this extension on the March 2016 draft guidance [1], industry groups have felt it necessary to voice their concerns publicly over the agency’s proposals.

A group of healthcare and pharmaceutical supply chain organizations stated in a letter submitted to FDA on 3 June 2016 that the agency should avoid requiring a statement of biosimilarity on the product labels of biosimilars. Such a statement ‘is at best unnecessary’ according to the group. They go on to say that ‘the FDA has never required any similar statement for products found to be therapeutically equivalent, and has not provided sufficient justification for its inclusion in biosimilar labelling’. They add that any such statement could also be ‘confusing to patients and providers who are unfamiliar with this type of unprecedented statement’ and that ‘this confusion could put biosimilar utilization, and savings, at risk’.

The Generic Pharmaceutical Association (GPhA) and the Biosimilars Council, although supporting most aspects of the draft guidance have also expressed concern that ‘the proposed biosimilarity statement may be confusing’. The GPhA’s letter, which was also submitted to FDA on 3 June 2016, states that ‘the proposed biosimilarity statement is unnecessary to the safe and effective use of biosimilars’. They therefore propose that the statement ‘be omitted in full compliance with FDA’s labelling regulations’. The GPhA goes on to say that the biosimilarity statement ‘does not provide any information that physicians or patients need in order to use the product in a safe and effective manner’.

The GPhA is concerned that ‘the biosimilarity statement may suggest to patients and healthcare professionals that biosimilars have clinically meaningful differences from their reference products in terms of safety, purity, or potency when, in fact, they do not’. This they say could ‘impede the uptake and use of biosimilar products and impair effective competition’.

FDA’s draft guidance on biosimilar labelling is open for comment until 2 August 2016. Electronic comments can be submitted to http://www.regulations.gov and written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, USA.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilars’ labelling [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 17]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-biosimilars-labelling

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