The following is an excerpt from a CME Corner with Gary H Lyman, MD, MPH, FASCO, FRCP, Fred Hutchinson Cancer Research Center, regarding biosimilar uptake in the US market, interchangeability designations, and use in oncology clinical pathways. The full CME Corner was published in the March 2020 issue.
The CME program titled, “Biosimilars and Oncology Clinical Pathways: Perfect Together” is currently available until December 10, 2020.
The most compelling reason to incorporate biosimilars into clinical pathways is certainly the same reason for incorporating biosimilars into other avenues of systematic clinical care, like guidelines and CME programs: to make sure that providers are aware of the availability of these agents, as it is a rapidly changing field.
Over this past year, the Food and Drug Administration (FDA) approved multiple biosimilars that are relevant to oncology. In the last 3 years, 23 biosimilars have been approved by the FDA for use in medical care in the US, the majority of which have relevance to oncology.
By being aware that these agents are available, and by incorporating them into pathways or guidelines, the reality is that they have been looked at very carefully not only by the FDA during their regulatory process—which is a rigorous and reasonably efficient process to protect safety and indicate the efficacy of these agents for approved indications—but also by the professional community when reviewing evidence and published literature for these purposes. Biosimilars are highly similar to their respective original biologic products that are safe and efficacious. These newer products provide an alternative to the originators.
The ultimate test will be whether the anticancer biosimilars for trastuzumab, rituximab, and bevacizumab will offer a meaningful price reduction to their expensive biologic therapies.
Lower prices will not only help reign in health care expenditures, but also improve access for patients with less financial means.