The US Food and Drug Administration’s (FDA) comment period on its guidance on the interchangeability of biosimilars with their reference biologicals ended on 19 May 2017 [1].
The agency received 52 comments on the draft guidance, which was first released in January 2017 [2]. Many of these comments came from big pharma companies, including AbbVie, Amgen, Boehringer Ingelheim, Genentech, Johnson & Johnson, Pfizer, Merck, Sandoz and more.
Many comments concentrated on the issues of switching studies and FDA’s requirements for interchangeability. But other issues raised included naming and labelling, definitions, extrapolation and exclusivity. This article covers comments on switching and labelling and naming.
1. Switching
AbbVie pointed out that ‘the draft guidance does not address the potential for medication errors associated with switching’.
Johnson & Johnson commented that it ‘strongly supports the agency’s strong recommendation that switching studies to demonstrate interchangeability should use only U.S.-licensed reference product’.
Sandoz, on the other hand, has ‘concerns’ with this and asks ‘the FDA to reconsider it in [the] final guidance’. Pfizer also has concerns with the use of a US-licensed reference product, saying that ‘this recommendation has the potential to create practical challenges with regard to where the study can be conducted’. The company suggests that ‘the Draft Guidance be modified to more clearly outline what the Agency’s expectations are for scientific justification of use of non-U.S.-licensed comparator’.
Merck also asked ‘that the final guidance include discussion of what types of scientific justification FDA would find acceptable to support the use of a non-U.S. licensed comparator’ in switching studies’.
Genentech says that ‘limiting the reference product to the U.S.-licensed product’ will ‘avoid potential differences in levels of specific structural features that could prime the immune system during switching and multiple exposures to each product’. However, it adds that ‘it would be helpful if FDA could provide the scientific rationale supporting the number of switches relevant to make certain the product is interchangeable. Why three switches instead of four, five or six switches?’
Pfizer points to the fact that the ‘FDA has not directly addressed the confusion on the topic of physician-mediated switching versus pharmacy-level substitution in a manner that would be visible to key stakeholders such as prescribing physicians, payers, and patients’.
2. Labelling and naming
Amgen said that ‘a statement of interchangeability and clinical data supporting interchangeability should be included in the product labeling’ in order to ‘facilitate appropriate use by healthcare professionals’. They added that ‘FDA guidance on non-proprietary naming for biologics should be applied in an identical manner to biosimilars and interchangeable products in order to mitigate inadvertent substitution and confusion by healthcare professionals’. Finally, they said that ‘FDA should establish an appropriate mechanism to reclassify a designation from an interchangeable to a biosimilar, should circumstances arise that warrant agency action’.
Johnson & Johnson argues ‘that both the highlights section and any patient labeling should include a statement about whether or not the biosimilar has been determined to be interchangeable with its reference product’. They also ‘request that the final naming guidance be modified to indicate that an interchangeable product will need a suffix that is distinct from the suffix of its reference product (and so distinct from the suffix of every other interchangeable product to the reference product)’. The company added that the FDA needed to address the ‘durability of interchangeability determinations’ in light of changes that ‘may occur that would raise questions and concerns about interchangeability’.
Genentech believes ‘that for prescribing and pharmacovigilance/safety reporting purposes, an interchangeable biological product should retain its unique identifier to distinguish it from the reference product: from biosimilars that are not interchangeable and from other interchangeable biological products to the same reference product’. They added that ‘labeling with respect to an interchangeable biological product should specify the specific reference product used in the interchangeability assessment, and precautionary statements warning against substitution with bioisimilar products that have not been designated as interchangeable, and other interchangeable biologic products to the same reference product but bearing a different 4 digit suffix’.
Pfizer says that ‘it would not be advisable for an interchangeable product to carry the same suffix as designated in the proper name of the reference product’. If they had the same suffix, Pfizer says this could ‘lead to inaccurate perceptions of the quality, safety, and effectiveness of interchangeable products vs biosimilars’ (which have different suffixes). Pfizer urges FDA to seek public comment on naming of interchangeable biological products as they develop their positioning’. The company also ‘recommends labeling of biosimilar and interchangeable biological products include an “interchangeability statement” that identifies whether or not interchangeability has been evaluated and outlines what is meant by interchangeability’.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA extends comment period for interchangeability guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Guidelines/FDA-extends-comment-period-for-interchangeability-guidance
2. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilar interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-on-biosimilar-interchangeability
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