FTC Endorses FDA’s Updated Biosimilar Interchangeability Guidelines: Enhancing Access or Creating New Uncertainty?

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Biosimilars versus Biologics

Biosimilars are a class of medications that provide safe and effective treatment for a wide range of illnesses includingchronic skin and bowel diseases, arthritis, and certain cancers.[1]  Unlike traditional “small molecule” drugs, biologics are typically derived from living organisms like yeast and bacteria and are much more complex in terms of structure, composition, and manufacturing.[2]  A biosimilar is a highly similar version of an already FDA-approved biologic and is designed to offer the same benefit.[3]  As such, approval of a biosimilar requires a demonstration that there are no meaningful clinical differences between the biosimilar and the original biologic.[4]  Biosimilars must also have the same route of administration, the same strength and dosage, and the same potential side effects as the original biologic.[5]

The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) created a streamlined application process for FDA approval, similar to the Hatch-Waxman Act in the context of small molecule drugs.[6]  The goal of the BPCIA is to increase competition and lower prices for consumers by reducing the time and resources required to obtain a biologics license.[7]  The BPCIA states that filing an “abbreviated Biological License Application” (“aBLA”) is an artificial act of infringement of patents covering the original biologic.  The BPCIA provides a process (known as the “Patent Dance”) for a biologic manufacturer (known as the “reference product sponsor”) to assert its patent rights against the biosimilar manufacturer.  This process services as a counter-balance measure to mitigate the effect biosimilar development and competition has on patent owners.[8]

Switching Studies and Interchangeability

In the United States, a biosimilar can be labeled as “interchangeable” if it can be substituted for a reference medication or original biologic at the pharmacy without additional approval from the prescribing physician.[9]  This designation, established by the BPCIA, ensures that biosimilars produce the same clinical results as the original biologic.[10]  To achieve this interchangeable designation, switching studies—studies conducted during the FDA-approval process—are used to demonstrate the interchangeability of the biosimilar and the original biologic.[11]

June 2024 FDA Draft Guidance

In June 2024, the FDA issued draft guidance titled “Considerations for Demonstrating Interchangeability with a Reference Product: Update.”[12]  This guidance discusses the criteria for demonstrating interchangeability with an original biologic.[13]  The guidance addressed the original requirement of switching study data for the FDA-approval of a “biosimilar with interchangeability,” and further stated that switching studies are not necessary to ensure the safety of biosimilars.[14] 

The June 2024 draft guidance was issued after experts continuously called for the removal of the switching study requirements for interchangeability.[15]  These experts noted that patients and providers may possess the misconception that biosimilars without an FDA interchangeability designation cannot be switched at all.[16]  Similarly, experts expressed concern about the high costs of performing switching studies.[17]  In response to these concerns, the draft guidance stated that companies seeking interchangeability status for their biosimilar could now have the option to submit switching study data, or alternatively, could simply state why the data in their current application clearly demonstrates that it is safe to switch the biosimilar for the original biologic.[18]  The FDA took comments on this revised approach until September 20, 2024.[19]

August 2024 FTC Comment

On August 20, 2024, the Federal Trade Commission (“FTC”) endorsed the FDA’s draft guidance.[20]  The FTC stated the new draft would streamline the approval process by accelerating the procedure, by reducing the administrative burden, and by lowering the cost to demonstrate the safety and effectiveness of switching from a biologic to a biosimilar.[21] Additionally, the FTC noted that this new guidance could reduce marketplace consumer confusion about the safety of different biosimilars, as well as reduce barriers to entry and foster competition by facilitating the interchangeability of more biosimilars.[22]

The FTC statement stated that “[t]he draft FDA guidance is a step in the right direction to fully realizing the goals of the [BPCIA] of 2009 to increase competition and innovation among biologics, which could lead to lower prices and increased choice for patients who depend on these life-saving medicines.”[23]   However, the FTC advised the FDA to issue further guidance for biosimilars not currently labeled as interchangeable to make it easier for acquiring this designation.[24]  The FTC believes this step could positively impact a larger population of patients, improve access to biosimilars, and give patients a broader range of safe and effective treatment options.[25]

References:

[1] See Food and Drug Administration, Biosimilar and Interchangeable Biologics: More Treatment Choices, FDA (Aug. 17, 2023), https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices (defining biosimilars and providing common examples of biosimilars used in daily practice). 

[2] See id. (noting because biologics come from living organisms, they are much more complex in nature).

[3] See id.

[4] Food and Drug Administration, supra note 1 (providing examples of properties biosimilars must have to be considered interchangeable).

[5] See id.

[6] See Gene J. Yao, Patents, Professional Perspective--The Biologics Price Competition and Innovation Act and the “Patent Dance,” Bloomberg Law (Oct. 2017), https://www.bloomberglaw.com/document/XS2K3IS000000#A0N3R6D8Q1-ref (describing the biosimilar approval process and patent litigation pathways for original biologic and biosimilar manufacturers).

[7] See id.

[8] See id.

[9] See Robert F. Schwartz & April B. Menon, FTC Submits Comment Supporting Proposed FDA Guidance Revising Switching Studies for Biosimilar Interchangeability, Lexology (Aug. 26, 2024), https://www.lexology.com/library/detail.aspx?g=c34eb054-7c11-4c70-bc64-480450c37e49 (describing the process of a biosimilar receiving an interchangeability designation); see Pfizer, 5 Things Worth Knowing About Biosimilars and Interchangeability, Pfizer (Dec. 12, 2023),  ttps://www.pfizer.com/news/articles/5_things_worth_knowing_about_biosimilars_and_interchangeability#:~:text=Some%20biosimilars%20have%20an%20additional,prescribing%20physician%2C%20state%20law%20permitting. (explaining the additional regulatory designation for biosimilars called interchangeability).

[10] See Ashley Gallagher, FTC Issues Support Statement for FDA’s Draft Guidance on Interchangeable Biosimilars, Pharmacy Times (Aug. 27, 2024), https://www.pharmacytimes.com/view/ftc-issues-support-statement-for-fda-s-draft-guidance-on-interchangeable-biosimilars (finding the interchangeability designation was created by the BPCIA due to the importance of substitution of the product by a patient’s pharmacist).

[11] See id. (describing switching studies as a requirement to demonstrate the interchangeability to demonstrate biosimilarity for FDA approval).

[12] See Considerations in Demonstrating Interchangeability with a Reference Product: Update, U.S. Food & Drug Admin. (2024) (Draft Guidance), https://www.fda.gov/media/179456/download (discussing FDA considerations for interchangeability using switching study or studies); see also Schwartz & Menon, supra note 9 (finding clinical switching studies were generally recommended to meet the FDA standard).

[13] See id.; see e.g., Gallagher, supra note 10.

[14] See id. (clarifying switching study data will no longer be required for the designation of interchangeability).

[15] See Skylar Jeremias, FDA Draft Guidance Removes Switching Study Requirements for Biosimilar Interchangeability, AJMC The Center for Biosimilars (June 20, 2024), https://www.centerforbiosimilars.com/view/fda-draft-guidance-removes-switching-study-requirements-for-biosimilar-interchangeability (stating some experts and politicians have proposed removing switching study requirements completely).

[16] See Joseph Park & Gillian Woollett, Confusion Persists Around the Interchangeability Designation for Biosimilars, Pharmacy Times ( Nov. 17, 2023), https://www.centerforbiosimilars.com/view/confusion-persists-around-the-interchangeability-designation-for-biosimilars (finding the legal and ordinary definitions of interchangeability are conflated due to a misconception that biosimilars lacking FDA regulation cannot be switched).

[17] See Jeremias, supra note 15 (stating switching studies can be a large expenditure because companies seek a “leg up” against competitors by receiving the seal of approval from FDA).

[18] See id. (noting companies seeking biologics license application would have option to submit switching study data or a statement); see also Schwartz & Menon, supra note 9 (finding the option would have a positive impact on number of biosimilars being designated as interchangeable).

[19] See id.

[20] See Federal Trade Commission, FTC Submits Comment Supporting Proposed FDA Guidance on Interchangeable Biosimilar Drugs, Federal Trade Commission (Aug. 20, 2024), https://www.ftc.gov/news-events/news/press-releases/2024/08/ftc-submits-comment-supporting-proposed-fda-guidance-interchangeable-biosimilar-drugs (finding the FDA’s draft guidance would increase competition, increase patient access, and lower healthcare costs).

[21] See id. (stating the draft guidance’s flexibility would expedite approval process).  

[22] See id.

[23] See Gallagher, supra note 10 (quoting FTC statement endorsing FDA draft guidance).

[24] See also Schwartz & Menon, supra note 9 (advising the FDA provide further guidance on existing biosimilars that may request interchangeable designation and stating that a majority of approved biosimilars are not designated as interchangeable).

[25] See id.