In response to an FDA request for comments regarding existing requirements for biologics and biosimilars, the American College of Rheumatology (ACR) submitted a letter identifying six “minimum components of review and oversight.” The FDA’s request for comments was made pursuant to President Trump’s executive order regarding the reduction of regulation and the associated costs.
The six factors identified by the ACR are:
- The use of “robust switching studies to determine whether alternating between a biosimilar and its reference product three or more times impacts the safety or efficacy of the drug.” This is designed to accommodate the multi-payer marketplace and changing formulary landscape. This recommendation supports the FDA’s draft requirement relating to such switching studies.
- “[C]linical trial development to focus on markers of immunogenicity.” The ACR also recommended allowing access to pharmacovigilance data for investigators to analyze, so that potential adverse effects could be more readily identified.
- “[E]xtrapolation of biosimilar treatment indications.” The ACR supports the identification of additional indications after careful study based on the mechanisms of action, bioavailability characteristics and adverse event profiles of biosimilars in order to expand indications and reduce drug prices.
- The use of “meaningful, distinguishing suffixes to help minimize ‘inadvertent substitution.” The ACR pointed to concerns about substitution of drugs not yet determined to be interchangeable rising from arbitrary or indistinct naming conventions.
- “[R]igorous trials to ensure safety and efficacy of biosimilars.”
- “[S]pecific budget authority for the FDA to support biosimilars.” The ACR encouraged the FDA to utilize the provisions of the Biosimilar User Fee Act II and the 21st Century Cures Act to draw the necessary resources to fully support the FDA’s efforts to ensure biosimilar safety and efficacy. The ACR further added that it believed that providing resources to support the emerging biosimilar market will lead to future cost savings and broader treatment access for patients.
The ACR’s full comments can be found here.
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