The FDA clarified a number of concerns surrounding the appropriate procedures for industry to apply for interchangeability status.
The FDA recently released a new draft guidance document to clarify submission procedures for applicants looking to gain licensing for a product seeking to be designated as an interchangeable biosimilar.
The question-and-answer document provides guidance for applicants as they formulate their submission documents in order to streamline the approval process.
Interchangeability designations are important to ensure patients have access to biosimilars as they allow for biosimilars to be administered in place of a reference product without a pharmacist needing to request approval from a physician first.
The FDA is accepting comments on the draft guidance until January 19, 2021. Guidance documents represent the agency's most current thinking about a subject, but are not legally binding.
In May 2019, FDA released long-awaited final guidance to clarify what data requirements are needed for a drug candidate to be licensed as an interchangeable biosimilar.
Gaining interchangeability status may require developers to conduct expensive and lengthy switching trials in additional to standard clinical trials, leading some physicians and researchers to call for the FDA to further revise their requirements. Currently, there are no biosimilars that have received this designation, however, a number of companies have expressed interest in seeking interchangeability status.
Information for New Biosimilar Applicants
For applicants who are submitting a biologics license application (BLA) under the 351(k) of the Public Health Services Act for a new biosimilar but also want to have an interchangeable designation, they should indicate that in an affirmative statement in the cover letter for the application.
“This approach provides for a more efficient and predictable review of BLAs,” wrote the FDA.
However, if an application contains sufficient information for a candidate to be licensed as a biosimilar but does not contain enough information to receive an interchangeability designation, the agency said that it would split the application, review the BLA as if it was only for biosimilar licensing, and update the applicant in a complete response letter of what supplement information is needed to obtain interchangeability.
Biosimilars Only If Interchangeable
The FDA also said that applicants can specifically request that the agency only license a drug candidate as a biosimilar if it is also deemed an interchangeable product by including the phrase “INTERCHANGEABLE-ONLY REVIEW” in the cover letter accompanying the BLA.
If the FDA needs to send a complete response letter to the applicant because of missing information, it will include deficiencies pertaining to licensing as a biosimilar and as an interchangeable biosimilar because a demonstration of biosimilarity is a required to receiving interchangeability approval.
Once an applicant receives a complete response letter, they “may then choose to amend and resubmit their application to address the deficiencies and support a demonstration of interchangeability or to amend and resubmit their BLA seeking licensure as a biosimilar product,” wrote the FDA.
BLA Holders and Labeling Statements
Under the guidance, applicants that already hold a BLA for a biosimilar should submit an original application to obtain interchangeability status under section 351(k). Applicants will still be able to market and distribute their biosimilar while their application is under review.
The FDA also included information on formatting labeling statements on interchangeability for BLA holders of an approved interchangeable biosimilar.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.