The FDA's evolving regulatory landscape for biosimilar interchangeability was a key topic at the GRx+Biosims 2024 conference. Discussions centered on the remaining challenges and the path forward, particularly concerning interchangeability labels in the US. Mustafa Unlu, PhD, JD, from the FDA, highlighted that the interchangeability designation is unique to US law and stems from initial concerns about the unknown risks of biosimilars.
Streamlining Interchangeability
Unlu explained that early fears regarding immunogenicity have not materialized, supported by data from switching studies and real-world evidence. He also discussed the FDA’s recent draft guidance, which removes the requirement for switching studies to achieve interchangeability status. This shift aims to streamline the interchangeability process and reflects growing confidence in the safety and efficacy of biosimilars.
Arlene Wolny, PhD, from Biocon Biologics, addressed historical concerns about immunogenicity and how interchangeability requirements have impacted stakeholders. She noted that the perception of interchangeables having a higher standard for approval is misinformation, as both biosimilars and interchangeable biosimilars must meet the same high-quality standards. Wolny emphasized the importance of reducing uncertainty through analytics and functional assays and praised the FDA's evolving guidance for its more streamlined approach.
Industry Perspectives and a Unified Standard
Jessica Greenbaum, JD, from Sandoz, echoed this sentiment, celebrating the FDA’s changing mindset regarding switching studies. She highlighted legislative proposals to eliminate the distinction between biosimilars and interchangeable biosimilars, advocating for a unified standard. Greenbaum pointed out the difficulties in maintaining separate pathways and stressed the need for early feedback to prevent development delays, arguing that a single standard would bring clarity and reduce the need for additional clinical data.
Addressing Misinformation and Promoting Education
The discussion also addressed the issue of misinformation surrounding biosimilars. Unlu emphasized the need for educational programs to boost biosimilar uptake, noting the FDA's role in creating educational materials and participating in professional conferences. He encouraged the industry to amplify the FDA’s educational efforts and engage with patients and clinicians to address concerns effectively.
Future Regulatory Flexibility
Looking ahead, Unlu explored hypothetical future scenarios, focusing on the need for more flexible regulatory standards to accommodate the diversity of biologics and streamline the interchangeability process. He also discussed the issue of first interchangeable exclusivity and called for more transparent FDA feedback to avoid delays.
Greenbaum concluded that further work is needed to ensure complications surrounding interchangeability are addressed, emphasizing the importance of reforming the system to ensure its meaningful impact.
