The Federal Trade Commission (FTC) is throwing its weight behind the FDA’s latest draft guidance on interchangeable biosimilar drugs—a potential game changer in patient access to lower-cost alternatives to name-brand biologic products.
First up: biologics.
To understand biosimilars, you’ll need to know about biologic drugs (known simply as biologics or biologicals).
- What they are: Composed of large-scale cell cultures and produced using any number of biotechnology methods and cutting-edge technologies, these types of drugs are used to treat serious medical conditions.
- Most importantly: They’re typically one of the most expensive types of prescription medicines.
Which brings us to … biosimilars?
Precisely. A biosimilar drug is—for lack of a better word—similar to its reference drug (ie: a biologic) in that it treats the exact same conditions as a reference biologic or name-brand drug with “no clinically meaningful difference, including in safety and effectiveness” according to the FTC.
- Other similarities:
- Composed of living cells or microorganisms
- Administered at the same strength and dosage
- Not expected to cause new or worsening side effects
The major differentiators: molecular size and structure, complexity of regulatory pathway (plus a proprietary vs repeatable manufacturing process for biosimilars and biologics, respectively), and cost of development.
Moving on to this original FDA guidance.
Issued in May 2019, Considerations in Demonstrating Interchangeability With a Reference Product (referred to as Interchangeability Guidance) was originally implemented prior to the FDA received/reviewed Biologics License Applications (BLAs) that were submitted for a proposed interchangeable biosimilar.
- Note: These BLAs were submitted under section 351(k) of the agency’s 1944 Public Health Service (PHS) Act, which was amended in 2009 (by the Biologics Price Competition and Innovation [BPCI] Act) to develop an abbreviated regulatory approval pathway for biosimilar drugs.
And the cause for these updates?
Since this 2019 publication, the agency has reported that the risks for safety and diminished efficacy noted in FDA-approved biosimilars has been “insignificant” when clinically studied against its reference product.
Gotcha. Now this new guidance.
Drafted in June 2024 by the FDA, Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), this new guidance proposes changes to the clinical application process for a biosimilar drug.
And this includes …
Specifically: The agency is removing its prior recommendation—which required a biosimilar drug application to submit “clinical switching studies” that demonstrate the drug’s ability to be interchangeable with the biologic reference drug.”
- Refresh: “Clinical switching studies” involve patients alternating between a reference drug and an interchangeable biosimilar in comparison to patients who do not alternate drugs.
- Also: The FTC has noted these studies to be “time-consuming” and “expensive.”
So what would the new recommendation involve?
In lieu of clinical switching studies, the FDA is proposing that a biosimilar drug applicant may submit a statement to the agency that explains why their drug’s existing data—as presented in a Biologics License Application (BLA)—would classify the drug as interchangeable.
Then: Once designated as an interchangeable, the biosimilar could be used by pharmacists to substitute that drug for a biologic—all without intervention from a prescriber.
And what does the FTC have to say about this?
Voting 5-0, the federal agency voiced its support for FDA’s guidance, noting “it will provide flexibility that may expedite the approval process and reduce the burden and cost of showing that switching a patient from a biologic to a biosimilar is effective.”
- Plus: The FTC stated that the current reliance on clinical-switching studies as a standard for establishing interchangeability has “likely contributed to marketplace confusion about biosimilars,” particularly among providers and patients.
Anything else?
Oh yes .. the Commission also urged the FDA to “provide further guidance on how already-approved non-interchangeable biosimilars may request an interchangeable designation.”
Why this is important: There is no guidance on how an already-approved biosimilar may request an interchangeable designation under the agency’s simplified regulatory process, according to the FTC.
- What this would do: By detailing this guidance for both approved and yet-to-be-biosimilars, the result would mean increased access for patients—not to mention a greater number of safe/effective options for patients.
- How this would be done: By increasing the number of biosimilars designated as interchangeables.
Was marketplace competition mentioned?
Most definitely—largely in regards to the need for federal agencies to be aware (and attentive) to the potential threat that anticompetitive practices could pose for enabling this wider patient access to biosimilars.
So in a nutshell?
The FTC concluded this new guidance would:
- Lower barriers to entry
- Simplify the approval process
- Help to dispel false impressions of separate safety/efficacy standards for interchangeables and other biosimilars
- Support increased competition in the biosimilar marketplace
Any other notable support for this guidance?
Yes! The Biosimilars Council also published its comments and support of this new guidance, specifically agreeing with the view that data from a switching study or studies should not be necessary to support licensure of interchangeable biosimilar medicines.
“An interchangeable designation has no bearing on the safety, effectiveness or quality of a biosimilar,” stated Craig Burton, executive director.
The Council noted that, in 2023, savings from the use of biosimilar medicines increased over 30%—to $12.4 billion.
Sounds like this guidance could be hugely impactful.
Indeed, particularly with the plethora of recent biosimilar clinical developments in the eyecare space within the last few weeks and months.
*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.