FDA issues draft guidance on biosimilars and interchangeable biosimilars labelling

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The US Food and Drug Administration (FDA) announced on 15 September 2023, the availability of a draft guidance for industry entitled ‘Labeling for Biosimilar and Interchangeable Biosimilar Products’ [1].

Label prescription drugs

FDA defines an interchangeable product as a ‘biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable medications’ [2], and can be substituted for the reference product without the intervention of the prescriber.

The draft guidance is intended to facilitate applicants in developing draft labelling for proposed biosimilar and interchangeable biosimilar products for submission in an application under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). This is an updated draft guidance following the version published in 2018 [3]. This update includes aspects relevant to interchangeable biosimilars.

In addition to this, other significant changes from the July 2018 guidance include recommendations on:

  • Product identification when the reference product labeling describes a clinical study conducted with a non-US-approved biological product. 
  • Pediatric use statement
  • Incorporating relevant immunogenicity data and information from the reference product labeling in the biosimilar or interchangeable biosimilar product labeling

The guidance outlines that the manufacturers should only include the drug product’s proprietary name in the following sections: indications and usage, dosage and administration, dosage forms and strengths, description and how supplied/storage and handling. FDA also recommended the use of a product’s proprietary name in recommendations for preventing, monitoring, managing, or mitigating risks. 

Furthermore, the guidance notes that manufacturers should make it clear when the biosimilar had only received licensure for a select number of the reference product’s approved treatment areas. There should be a clear statement regarding the therapy’s biosimilarity as a part of the label.

The draft guidance may omit the description of the interchangeable designation on the product labels. The agency said that including an explanation of the interchangeability standard on labels ‘is not likely to be useful to prescribers, who can prescribe both biosimilar and interchangeable biosimilar products in place of the reference product with equal confidence that they are as safe and effective as their reference products’.

On the other hand, a biosimilar standard unique to the US, an interchangeable biosimilar, has provided additional data to FDA, which demonstrate that not only is the product safe and effective, but that any given patient can be repeatedly switched between it and the reference product and expect the same result without additional risks. Under US state law, only interchangeable biosimilars may be automatically substituted at the pharmacy level without physician involvement [4].

FDA has released the draft for a comment period of 60 days, i.e. until 17 November 2023. Comments can be submitted online at https://www.regulations.gov/docket/FDA-2016-D-0643, or in written form, and can be mailed to Dockets Management, FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, USA. All written comments should reference the docket no. FDA-2016-D-0643. When finalised, the guidance document will replace the agency’s 2018 ‘Labeling for biosimilar products’ [2].

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1. Labeling for Biosimilar and Interchangeable Biosimilar Products. https://www.fda.gov/media/172170/download
2. GaBI Online - Generics and Biosimilars Initiative. FDA releases new information on interchangeable biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 22]. Available from: www.gabionline.net/biosimilars/general/FDA-releases-new-information-on-interchangeable-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. FDA issues guidance for labelling biologicals and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 22]. Available from: www.gabionline.net/guidelines/FDA-issues-guidance-for-labelling-biologicals-and-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. 45 US states have passed biosimilar substitution laws [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Sep 22]. Available from: www.gabionline.net/policies-legislation/45-US-states-have-passed-biosimilar-substitution-laws

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