ACR Calls on FDA to Maintain Rigor on Biosimilars

The American College of Rheumatology (ACR) submitted a comment letter to the FDA on December 7, 2017, in response to the agency’s request for comments and information on existing requirements for biologics and biosimilars. The request followed President Trump’s Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”) as the FDA sought input on the ways in which it could modify existing regulations and related paperwork without compromising its public health mission.

While ACR praised the agency for considering opportunities to reduce regulatory burden, the organization called on the FDA to focus on 6 “minimum components of review and oversight” for biosimilars:

• The use of robust switching studies for biosimilar products. The use of at least 2 exposure periods to each drug in a switching study will mirror a patient’s real-world experience with evolving formularies in a continually changing marketplace, and multiple switching studies to demonstrate interchangeability are vital to ensure safety, said the letter.
• A focus on immunogenicity in clinical trials. Immunogenicity data are critical for providers to be able to assess efficacy of a therapy or the need to switch a patient’s treatment, and the ACR asked the FDA to allow ready access to pharmacovigilance data.
• Extrapolation of indications. ACR called extrapolation “crucial for the biosimilar pathway to reduce drug prices.”
• Meaningful suffixes. The organization called on the FDA to require meaningful, distinguishable suffixes to be appended to the nonproprietary names of biosimilars to help minimize potential problems with inadvertent substitution or hampered pharmacovigilance.
• Rigorous trials. ACR added that it supports a robust review of trial data to ensure that biosimilars are safe and effective.
• Addition of an FDA budgetary authority to support biosimilars. ACR’s letter called for the establishment of a specific authority within the agency, focused on biosimilars, to ensure support for industry guidance and drug approvals.

In an interview with The Center for Biosimilars^®, Angus Worthing, MD, FACR, FACP, chair of ACR’s Government Affairs Committee, highlighted the reasons for the organization’s call for a budgetary authority; “The pipeline has several dozen candidate drugs, and there are many openings at FDA for people to evaluate [those products],” said Worthing. It is crucial to hire staff to fill these positions, and a guaranteed budget would “help to create some stability to hire the experts they need” to facilitate the timely approval of more biosimilars.

Another notable component of the ACR’s letter is its call for meaningful suffixes for biosimilars; like many organizations, ACR finds the FDA’s current practice of assigning non-meaningful suffixes potentially problematic, as many stakeholders find the suffixes difficult to remember.

“One potential reason that the FDA might have random suffixes right now might be to avoid attaching a specific manufacturer’s name to a product in case a product gets sold to a different company,” Worthing posited, but he noted that, “If you think about it, a connection between a company [and a product] might help incentivize that company to promote the drug’s safety and effectiveness and make sure that the drug works well for patients.” While the ACR does not have a strong position on what kind of meaningful suffix—whether manufacturer-specific or otherwise—is given to biosimilars, it supports the memorability of these designations to promote good pharmacovigilance.

Also key to pharmacovigilance, said Worthing, is ensuring that patients and providers are aware of how to report any adverse events related to their therapies, making sure that reporting structures are efficient and easy to use, and ensuring that the data collected are made available: “Once we get data coming in about adverse events, it’s important not to keep that data bottled up,” Worthing said.

Looking ahead, Worthing welcomes the eventual approval of interchangeable biosimilars as a way to promote the uptake of these cost-saving therapies.

“Unfortunately, despite the FDA doing good work and manufacturers providing data to the FDA, these drugs are not accessible right now. That gets us more excited to see approval of interchangeable drugs,” which will be substitutable at the pharmacy level as regulated by state law. “I think doctors will have a lot more confidence in biosimilars that are interchangeable,” said Worthing, “and that will improve the transition and improve treatment.”