FDA issues Q & A on biosimilars

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The US Food and Drug Administration (FDA) issued draft Questions and Answers (Q & A) on biosimilars development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) in November 2020.

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This guidance document hopes to inform prospective biosimilar product applicants and aid in the development of proposed biosimilar and interchangeable products. It also intends to describe the statutory requirements added by the BPCI Act. When finalized, the Q & A will be moved to the final Q & A guidance on biosimilar development [1].

Biosimilarity and interchangeability
Initially, FDA outlines how applications for interchangeable biosimilars that have data to support being licensed as a biosimilar but not as an interchangeable product [2] will be handled. Here, it notes that 351(k) submissions for interchangeability will only be reviewed if the application includes a statement indicating that the information contained within the submission meets the standards for interchangeability described in section 351(k)(4) of the Public Health Service Act.
If a situation were to arise where a biosimilar application was submitted without the statement to verify interchangeability, then FDA outlines that it will split the application for administrative purposes. This will allow FDA to take separate actions on the biologics license application (BLA). Here, FDA could license the product as a biosimilar and let the applicant know of the deficiencies in the application that have prevented it being licensed as an interchangeable biosimilar. To be licensed as an interchangeable product, the applicant would be required to submit supplementary data to support this. However, if an applicant does not wish for their biosimilar to be approved unless it is also deemed interchangeable, they can request an ‘interchangeable-only review’.

The position for existing biologicals license holders
The Q & A then discusses how current biologicals license holders should proceed to seek approval for a biosimilar or interchangeable of their own product. Here, it is outlined that, as for all biosimilar and interchangeable applications, an application must be submitted under section 351(k) citing the reference product and containing information that supports biosimilarity and/or interchangeability.

The FDA Q & A also explains which labelling provisions that are included in its guidance Labeling for Biosimilar Products apply to interchangeable products.
In addition, FDA explains that biologicals license holders of approved interchangeable biosimilars need to include a labelling statement on interchangeability. This should be included in the Highlights of Prescribing Information section of the label and placed immediately under the Initial US Approval section.
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1. U.S. Food and Drug Administration. Questions and answers on biosimilar development and the BPCI Act [homepage on the Internet]. [cited 2010 Dec 4]. Available from: https://www.fda.gov/media/119258/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 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/General/FDA-releases-new-information-on-interchangeable-biologicals

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