Gary Lyman, MD, MPH, an oncologist and hematologist, discusses how biosimilars have fared in the oncology space compared to other therapeutic areas.
Gary Lyman, MD, MPH, is an oncologist, hematologist, and public health researcher who has long been an advocate for biosimilars. He has also developed guidelines in support of using these biosimilars in the oncology space.
Could you briefly explain how biosimilar uptake in the oncology space differs from that in other spaces, such as rheumatology?
As an oncologist, of course I'm most familiar with the agents approved and utilized within oncology, within cancer treatment and supportive care. I'm certainly not appraised of all the indications and uptake of agents used outside the oncology space. I do know that in rheumatology and selected other areas that biologics have had a major impact on patient care and treatment and outcomes, and I would anticipate they will be as aggressively evaluated and taken up as in oncology.
The majority of FDA-approved biosimilars are in the oncology space. I think, when I last looked 17 of the 29 approved biosimilars are drugs that we use routinely in oncology, either for supportive care—like hematopoietic growth factors—or for actual cancer treatment. So, they've had a dramatic impact in oncology, including the very first biosimilars approved in the United States were supportive care biosimilars for oncology.
Biologics have impacted dramatically across medical disciplines in many areas. As the patents expire on these agents, all of which have increased substantially in price since their original approval, and this can often limit access or willingness to utilize. I think, there's no question that the introduction of biosimilars is having a fairly substantial effect across disciplines.
I can speak to oncology, again, that guidelines made from major professional organizations including ASCO [American Society for Clinical Oncology], the NCCN [National Comprehensive Cancer Network], and Europe, as well, have embraced biosimilars. In fact, in a forthcoming updated policy statement from ASCO, they reiterate their policy and position that biosimilars are equally valuable options to originators when they're approved by the FDA for in for use in oncology.
So, not a direct answer to your question, typically, because I don't have a lot of data outside of oncology, but I see no differences in the regulatory process in safety and efficacy concerns. Perhaps in oncology, my biased perspective is that the diseases that we manage are often life-threatening and more serious. This both raises the importance of providing access to these expensive therapies, but could raise concerns from a clinical perspective that if there was any compromise of the efficacy of a biosimilar, there could be impacts on patient outcomes, longevity, survival. But we've seen none of that with the anticancer biosimilars. While they're more recent, generally approved the last 2 or 3 years they've been approved, it does appear that they're being integrated into oncology guidelines and utilized in practice fairly routinely and increasingly.