FDA offers new Q&A on biosimilars and interchangeable products
Regulatory News | 20 November 2020 |
In a draft questions and answers guidance issued Thursday, the US Food and Drug Administration (FDA) offers insights into how it will handle certain aspects of submissions and labeling for interchangeable biosimilars.
When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development.
In the first of four questions and answers in the draft guidance, FDA explains how it anticipates handling applications for interchangeable biosimilars that include data to support licensure as a biosimilar but not as an interchangeable product.
First, FDA notes that it only intends to review 351(k) submissions for interchangeability if the applicant provides a statement in the application 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 such a situation were to arise, FDA says it “intends to split the application for administrative purposes,” allowing the agency to take separate actions on the biologics license application (BLA).
“For example, FDA could license the product as a biosimilar product and convey deficiencies in the application for licensure as an interchangeable biosimilar to the applicant in a complete response letter, and FDA could make a determination of interchangeability for the product upon submission of a supplement that contains all data and information necessary to support licensure of the product as an interchangeable biosimilar,” FDA writes.
But if a company does not wish for their biosimilar to be approved unless it will be deemed interchangeable, applicants may request an “interchangeable-only review.”
The second new question and answer deals with how BLA holders should proceed if they wish to seek approval for a biosimilar or interchangeable to their own product. As with any other biosimilar or interchangeable, FDA says the originator would do so by submitting an original application under section 351(k) citing the reference product and containing information to support biosimilarity or interchangeability.
For the third question, FDA explains what labeling provisions included in its guidance Labeling for Biosimilar Products apply to interchangeable products.
In the fourth and final question, FDA explains that BLA-holders of approved interchangeable biosimilars should include a labeling statement on interchangeability placed immediately beneath the Initial US Approval portion of the Highlights of Prescribing Information section of the label.
FDA
When finalized, FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development.
In the first of four questions and answers in the draft guidance, FDA explains how it anticipates handling applications for interchangeable biosimilars that include data to support licensure as a biosimilar but not as an interchangeable product.
First, FDA notes that it only intends to review 351(k) submissions for interchangeability if the applicant provides a statement in the application 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 such a situation were to arise, FDA says it “intends to split the application for administrative purposes,” allowing the agency to take separate actions on the biologics license application (BLA).
“For example, FDA could license the product as a biosimilar product and convey deficiencies in the application for licensure as an interchangeable biosimilar to the applicant in a complete response letter, and FDA could make a determination of interchangeability for the product upon submission of a supplement that contains all data and information necessary to support licensure of the product as an interchangeable biosimilar,” FDA writes.
But if a company does not wish for their biosimilar to be approved unless it will be deemed interchangeable, applicants may request an “interchangeable-only review.”
The second new question and answer deals with how BLA holders should proceed if they wish to seek approval for a biosimilar or interchangeable to their own product. As with any other biosimilar or interchangeable, FDA says the originator would do so by submitting an original application under section 351(k) citing the reference product and containing information to support biosimilarity or interchangeability.
For the third question, FDA explains what labeling provisions included in its guidance Labeling for Biosimilar Products apply to interchangeable products.
In the fourth and final question, FDA explains that BLA-holders of approved interchangeable biosimilars should include a labeling statement on interchangeability placed immediately beneath the Initial US Approval portion of the Highlights of Prescribing Information section of the label.
FDA
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