Approaching the Topic of Biosimilars With Patients

Yelena Y. Janjigian, MD

As the reality of the use of biosimilars for cancer treatment nears, oncologists need to familiarize themselves with the information available in order to effectively discuss these agents with their patients, according to Yelena Y. Janjigian, MD.

Currently, the only biosimilar used in patients undergoing cancer treatment is filgrastim-sndz (Zarxio), which is a biosimilar for the G-CSF analog filgrastim (Neupogen). Biosimilars for trastuzumab (Herceptin) and bevacizumab (Avastin) have been FDA approved but are not yet available for use. Additionally, the FDA’s Oncologic Drugs Advisory Committee is scheduled to discuss a biologics license application for CT-P10, a proposed rituximab (Rituxan) biosimilar.

Although biosimilars for the treatment of patients with cancer are not yet on the market, Janjigian said that oncologists should read up on the available literature so they can adequately inform patients when the time comes. Once these agents are available for use, she explained that it is important to have an open line of communication with the patient receiving the biosimilar. This includes assuring the patient that efficacy and safety remain the same between the reference biologic and the biosimilar.

OncLive: Where are we in the United States regarding the development and approval of biosimilars?

Why do you believe there is a lack of knowledge on biosimilars?

In an interview with OncLive, Janjigian, a medical oncologist at Memorial Sloan Kettering Cancer Center, discussed the reality of biosimilars entering the US market and how oncologists should approach discussing these agents with their patients.Janjigian: In the United States, we are in the early stages of biosimilar approvals. Most patients are treated with the parent compound. Filgrastim-sndz is the only biosimilar is that being used right now. It is a [G-CSF analog] used to boost white blood cells.It is a new concept; most patients know very little. What they know they learn from their doctors. Especially in the United States, where we have relatively good access to targeted agents, biosimilars have not really taken a foothold yet. There is not really a reason for doctors to consider it yet, as most hospitals carry the name brand compounds. Places where biosimilars have been studied the most and have been heavily pursued are in countries where perhaps some of these expensive targeted agents or biologic agents are unavailable due to cost. If the doctors never use it, they won't talk to their patients about it.

There are some biosimilars in development for the treatment of patients with cancer. What can oncologists do to familiarize themselves with these agents before they come to market?

Once biosimilars come to market, what is important for physicians to understand?

Biosimilars may be an option in countries where some of these expensive biologic agents may not be available, and whether they will dominate the market in the United States and more developed countries is yet to be determined. As we are trying to curb the cost of healthcare in the United States, biosimilars are supposed to be a more affordable alternative. They will gain some traction, but that remains to be identified.Oncologists need to follow the literature and the FDA approvals of these agents. Especially for doctors who work in larger hospitals, it will come down to the hospital decision for the formulary. The message that we need to convey is that these agents have the same efficacy and activity, but a lot of it will come down to availability. We are in an era where cancer drugs are becoming extremely expensive and if we are able to curb some of the costs, it would be a positive for our community.[It is important to have] perception and an understanding of what biosimilars are. It is a common misconception that it is a generic form of the same medicine. With a biologic therapy, these agents are made in the lab, so it is important to realize that biosimilars have the same mechanism of action and act in the same way because they hit the same targets. It is important to know that a lot of the research and development that has been accomplished and the toxicity profile has been established for the biosimilars.

What it comes down to is patient perception and physician comfort. Often, patients might not necessarily be aware of what they are getting, but clear communication is important. Everyone should be on the same page.