Suggestions for Biosimilar Research Roadmap
Five stakeholders are making suggestions they say will improve the Biosimilar Regulatory Research Pilot Program Roadmap issued as part of the third biosimilars user fee (BsUFA 3) reauthorization. Sandoz says it is a “strong supporter” of the regulatory research on biosimilars outlined in BsUFA 3. It expresses an “overarching concern” about linking the roadmap’s two goals and also says all proposed research projects should be linked to the program’s goals. “Research into advanced analytics should be undertaken only if the analytics can streamline development and further or reduce/eliminate studies with human subjects,” the letter says.
The Association for Accessible Medicines’ Biosimilars Council says the research priorities in the roadmap are “a good starting point” for improving and streamlining the assessment of biosimilar medicines. However, it says, the council is concerned that the scope of research and work needed to make progress on 10 priority areas is too much to attempt concurrently, especially when the program is being established. It recommends FDA work with stakeholders to further prioritize the research agenda and then to allocate research funding to a broad variety of high-priority projects.
The comment letter from the Biosimilars Forum says a higher research priority should be given to improving the efficiency of biosimilar development. “We believe this is key to the future of biosimilars and our ability to provide access for patients to critical medicines,” the letter says. “Notably, none of the efficiency that the Forum proposes in any manner change the quality, safety, or efficacy of the biologics finally approved, whether as biosimilars or as interchangeable biologics. The Forum encourages FDA to ensure that the research being undertaken in this program specifically and directly addresses the goals of the BsUFA 3 regulatory research pilot program and not include basic research that may only be peripherally related, if at all.”
Pharmaceutical Research and Manufacturers of America urges FDA to provide timely updates on milestones and/or results from each of the demonstration projects, including any incremental findings regarding improvements to the efficiency of biosimilar and interchangeable biosimilar product development, and the intended outcomes of the selected research projects.
Finally, Samsung Bioepis says it is concerned that some of the research priorities that have been selected by the agency are neither feasible nor would lead to improvements in the efficiency of biosimilar product development. “It is a key priority that every project funded is regulatorily relevant and specifically applicable to biosimilars,” the letter says.