Streamlining Biosimilars: FDA's Draft Guidance Signals Big Changes (Part 2)

This is a continuation of our Behind the Bill on the FDA’s new guidance for biosimilar interchangeability. If you haven't read part 1 yet, you can find it here.

ICYMI: In a significant development for the pharmaceutical industry, the Food and Drug Administration (FDA) has proposed new guidelines that could streamline the approval process for interchangeable biosimilars. This draft guidance, issued on June 20, 2024, suggests that manufacturers may no longer need to conduct extensive clinical switching studies to prove interchangeability. Instead, they can leverage existing data on their biosimilar's structure and performance. This shift is based on the FDA's findings that approved biosimilars pose minimal risk in terms of safety or efficacy when switched with reference products, and it reflects advancements in analytical technologies for characterizing therapeutic proteins. The proposed changes aim to accelerate the availability of interchangeable biosimilars in the US market, potentially reducing health care costs and improving patient access to these medications.

The ACR Weighs In

On August 20, 2024, the American College of Rheumatology (ACR) submitted a letter to the FDA, praising the agency for its updated guidance. The ACR, representing over 9600 rheumatology professionals, has long supported the use of biosimilars to treat various rheumatic diseases and reduce costs.¹

The ACR views the FDA’s decision to remove the switching study requirement as a significant step towards increasing access to interchangeable biosimilars. They note that this change could substantially decrease the investment needed to obtain approval for an interchangeable biosimilar, potentially leading to more options for patients and reduced costs.¹

Balancing Progress with Caution

Although the ACR supports the FDA’s decision to lower this standard, citing increased access to interchangeable drug products, they also urged caution. The organization emphasized the need for continued scientific rigor to protect patient safety and expressed concerns about potential downstream effects.¹

One key issue raised by the ACR is the risk of pharmacy-level substitutions occurring without timely notification to the prescribing provider and patient. They stress the importance of transparency in all pharmacy-level switching, advocating for timely information to both the prescriber and the patient when a switch occurs at the pharmacy counter.¹

Legislative Context: The Evolving Biosimilars Landscape

While the FDA is updating its guidance on interchangeability, Congress is also taking steps to promote the adoption of biosimilars. A key piece of legislation in this area is the Increasing Access to Biosimilars Act of 2023, introduced in the House of Representatives on March 3, 2023.²

Key provisions of the Increasing Access to Biosimilars Act include:²

• Demonstration project: the bill requires the Secretary of Health and Human Services to establish a 3-year nationwide demonstration project under Medicare Part B. This project aims to evaluate the benefits of providing a shared savings payment for biosimilar biological products.
• Voluntary participation: health care providers can voluntarily participate in the demonstration project, with the flexibility to terminate their participation at any time.
• Additional payments: under the project, participating providers may receive an additional payment when furnishing biosimilar products. This payment would be based on the difference between the cost of the biosimilar and the reference biological product.
• Patient cost protection: importantly, the bill stipulates that these additional payments should not increase Medicare beneficiaries’ cost-sharing liabilities.
• Reporting requirements: the Secretary is required to submit both interim and final reports to Congress, analyzing the appropriateness of expanding or extending the demonstration project.

This legislative effort, coupled with the FDA’s new guidance, reflects a concerted push to increase biosimilar adoption and competition in the biologics market. By potentially making biosimilars more financially attractive for providers to prescribe, this bill complements the FDA’s efforts to streamline the approval process for interchangeable biosimilars.

Now, the question remains whether the 118th Congress will be able to pass this legislation before their final session in January.

Looking Ahead: Implications for the Health Care Ecosystem

The FDA’s new stance on interchangeability could have far-reaching effects on the US health care system. By potentially increasing the number of interchangeable biosimilars on the market, we may see:

• Increased competition leading to lower prices for biological medications • Improved access to these life-changing therapies for patients
• Shifts in prescribing patterns as more options become available
• New challenges for originator companies in maintaining market share
• Potential savings for public and private payers

However, as the ACR points out, this progress must be balanced with robust safeguards to ensure patient safety and maintain the integrity of the prescriber-patient relationship. The implementation of these changes will require careful monitoring and potentially additional guidance from regulatory bodies.

As we move forward, it will be crucial to track how these changes play out in practice. Will we see the anticipated surge in interchangeable biosimilars? How will this affect drug pricing and patient access? And how will stakeholders adapt to this new landscape? The biosimilars market is at a pivotal juncture, with policy changes potentially reshaping the competitive landscape.

Join me every Wednesday as I highlight key court decisions, review notable health policies, and analyze what’s behind the bill in health care. Behind the Bill is taking a brief hiatus to attend the Clinical Pathways Congress + Cancer Care Business Exchange conference in Boston, but we'll see you on September 18th. 

References

1. American College of Rheumatology. Letter to FDA Administrator Robert Califf. August 20, 2024. https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/blt1beaaa3f4e28ff65/advocacy-letter-fda-interchangeability-guidance-comments.pdf

2. Increasing Access to Biosimilars Act of 2023, HR 1352, 118th Cong. (2023).