Journal of Clinical Pathways spoke with Gary Lyman, MD, MPH, professor of medicine, University of Washington, and co-director, Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, regarding the process of bringing oncology biosimilars to market and their potential uptake in clinical practice as well as pathways.
What are the most notable challenges in bringing oncology biosimilars to Food and Drug Administration (FDA) approval?
Dr Lyman: Many of regulatory policies for biosimilar approval have been set by the FDA such that manufacturers know the regulatory ground rules and what is required. The FDA still reserves the right to require comparative clinical studies if there is residual uncertainty that the biosimilar is highly similar to the reference product after evaluating preclinical analytical and animal studies as well as human PK/PD, immunogenicity, and toxicity data. Such additional requirements may include dose ranging, efficacy, and safety studies.
What impact do you expect oncology biosimilars to have on standard-of-care procedures? Is the impact already happening?
Dr Lyman: Biosimilars have had a major impact on available cancer treatment options in Europe over the past decade. In the US, we are already observing an impact of biosimilars on therapeutic options and utilization in supportive care of patients receiving cancer chemotherapy with multiple biosimilar of the myeloid growth factors. Nevertheless, the impact of biosimilars in the market on drug pricing and overall health care costs is not yet clear. Existing experience suggests that it may require more than one competitive biosimilar to begin to drive down drug prices.
It is too early to assess the possible impact on cancer-directed treatment—such as monoclonal antibodies—because biosimilars have only very recently been approved. Clearly, there is a higher level of concern among clinicians and patients in terms of the utilization of biosimilar versions of these agents, as any loss of efficacy or increase in toxicity could have a more direct impact on the patient’s disease course and potential curability. I anticipate that the uptake in use of these agents will be somewhat slower than that of the supportive care agents or as has been observed in more regulated health systems. This will require time and experience with these agents and continued education efforts that provide a full understanding of the rationale for regulatory review, approval, and existing favorable experience elsewhere in the world.
What cost and regulatory considerations must be weighed for oncology biosimilars to be translated into clinical pathways?
Dr Lyman: Regulatory approval, of course, is only one step in the process and does not lead automatically to the integration of a new agent into clinical practice guidelines, clinical pathways, and subsequently into clinical practice. We have already seen that there is a need for full transparency of reporting of both preclinical and clinical data—including safety and efficacy studies—in order for biosimilar agents to be embraced by the clinical community. Clinical practice guideline panels have been reluctant to recommend the use of biosimilars when supporting data provided to the FDA at the time of regulatory approval are not publicly available, either through presentation to a Drug Advisory Panel or by publication in the peer-reviewed medical literature. It will be important that the data considered by the FDA in approving biosimilars be available for full review by clinicians, patients, and developers of evidence-based clinical practice guidelines and pathways.
How are oncology biosimilars likely to change the clinical pathway landscape in years to come?
Dr Lyman: Biosimilars and clinical pathways are important and essential complementary approaches to improving the quality of cancer care and reducing health care costs, leading to improved access to rapidly evolving, effective, and safe treatments while reducing economic disparities. Integration of biosimilars in clinical guidelines and pathways is essential to a sustainable and equitable health care system for optimal cancer care delivery and outcomes.
Dr Lyman co-leads an on-demand webcast on biosimilars and value-based oncology treatment pathways that offers CME and CPE credit and is available until November 30, 2018. To access this webcast, click here.