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Lead Author Explains ASCO's Statement on Biosimilars in Oncology

Angelica Welch
Published: Thursday, Apr 26, 2018

Gary H. Lyman, MD, FASCO
Gary H. Lyman, MD, FASCO
ASCO recently released a statement outlining the organization’s commitment to education and guidance regarding the use of biosimilars in the treatment of patients with cancer, which was published in the Journal of Clinical Oncology.

The statement focused on the value of biosimilars in oncology, naming and labeling, safety and efficacy, interchangeability, and prescriber and patient education.

“ASCO's goal is primarily to educate and inform the oncology community, and in turn, the patients that we represent,” said Gary H. Lyman, MD, FASCO, the lead author of this statement. “Also, what questions to ask, and why we feel that the processes that have been put in place by the FDA and professional organizations should ensure the safety and efficacy of these agents if they are used to treat cancer.”

In an interview with OncLive, Lyman, who is the co-director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutchinson Cancer Research Center, and a member of the ASCO board of directors, discussed these areas of focus in detail, highlighting the clinical implications of biosimilars for oncologists to recognize.

OncLive: Why did ASCO decide to release this statement?

Lyman: Biosimilars is a pretty hot topic right now. We are certainly in the biologic revolution in oncology with the introduction of various effective, but often costly, biologic therapies for many forms of cancer. These include monoclonal antibodies and small molecules like tyrosine kinase inhibitors. These are products produced in living systems, so they are not chemically synthesized in the laboratory the same way that conventional drugs have been. While these have produced startling advancements in the treatment of many cancers, they have come at a heavy price tag because they are very costly to develop, get regulatory approval for, and so forth. There is a lot of concern in general about the rising cost of healthcare, particularly drug prices for cancer treatment, and the major drivers of these rising costs are these biologic therapies. 

One of the opportunities that is certainly being explored to curtail or bend the cost curve that has been rising for decades is to increase competition. As some of these products have their patents expire, other companies are seeing an opportunity to develop similar biologic therapies and get them approved to compete. Unlike generics, which can be synthesized in the laboratory and are virtually identical to the parent drug, these are products that are produced in living systems that we cannot necessarily replicate exactly. They may have the same amino acid sequence and functional properties, but they will not be identical to the original biologic. Therefore, they are called biosimilars. The FDA formally defines these as a biologic product that is highly similar to a reference biologic product for which there is no clinically meaningful difference in safety, purity, and activity. 

We have had supportive care biosimilars in oncology for the myeloid growth factors GCSF, or filgrastim (Neupogen). The FDA recently approved a couple of biosimilar cancer therapies, including the biosimilar versions of trastuzumab (Herceptin) and bevacizumab (Avastin). These are not yet available for a variety of technical and legal reasons, but they soon will be.

Coming down the pike are literally dozens of these exciting agents. There are a number of companies waiting in the wings for these patents to expire to jump in and become part of that market. The good news, for us, is that the Europeans have been doing this for several years and relatively successfully. A number of biosimilars have been approved in the oncology space and no major critical safety issues have emerged.

It remains to be seen whether the US healthcare system will respond in the same way. The hope is that with increased competition, there will be some reduction in pricing, as there has been with generics and more conventional drugs. Over time, that will mean more patients will get access to these biologic therapies and the cost will not be as prohibitive or burdensome to patients and the healthcare system. It is going to be interesting to see how it all plays out over the next several years in the United States.

ASCO just felt, as the largest professional oncology organization in the world—servicing the vast majority of cancer specialists in the country, including oncologists that use these drugs—it was important to make sure that we are all up to speed on this. And, that we [should] better understand what biosimilars are, why they are being made, how they are being made, how they are approved, and basically to educate the oncology workforce so they themselves can better understand and inform their patients on the benefits, harms, and rationale for using these agents.

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