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Professor of Medicine, Temple University
Chief, Medical Oncology & Hematology
St Luke's Cancer Center
Sanjiv S. Agarwala, MD, has no real or apparent conflicts of interest to report.
Biosimilars are showing promise in making oncology treatments more affordable and accessible. But are our patients ready?
To me, the primary challenge of gaining acceptance for biosimilars among patients will be dispelling the notion that the original reference biologic is somehow more effective than its biosimilar.
Imagine you treat a patient with a biosimilar and the patient’s cancer progresses or does not respond—is the patient going to wonder if the results would have been better if they had received the reference biologic instead of the biosimilar?
As oncologists, we understand that any biologic’s efficacy in a given patient is not guaranteed, but it may be difficult to convince a patient whose disease has progressed while receiving a biosimilar. It will be up to clinicians to find effective ways to explain to patients the reasons why biosimilars are essentially equivalent to their reference biologics.
Variability of Biologics
If a patient in my care were concerned that a biosimilar is not the same drug as its reference biologic, I would offer the following logic. If you are treated with a biologic today and a month from now, you are treated with the same biologic but from a different batch, then there is as much variability between the 2 batches of biologics as there is between the reference biologic and its biosimilar.
In other words, a biosimilar is not the same as a generic; it is not a carbon copy of the original biologic because even the original biologic differs from batch to batch. This is the nature of all biologics, which are made in living systems, vs simpler drugs that are made in a chemistry lab.
Proof of Equivalence
Any biosimilar approved in the United States has been proven to be clinically similar in safety and efficacy to its reference biologic through a logical and rigorous testing process overseen by the FDA. Proving that a biosimilar is equivalent to its reference biologic means that there are no clinically meaningful differences in terms of mechanism of action, safety, purity, and potency between the 2 drugs; they are essentially the same drug. In every biosimilar approved in the United States so far, this proof has included phase III clinical studies demonstrating equivalent efficacy. This rigorous approval process should provide enough comfort that a biosimilar is as effective as its reference biologic.
Because of the lower cost vs reference biologics, insurance will likely also play a role in driving patient acceptance of biosimilars. A patient who has good insurance with no copay and full coverage may decline a biosimilar in favor of the more expensive reference biologic, whereas a patient who has a high copay may be more inclined to choose the less expensive biosimilar.
Overall, the lower cost of biosimilars will allow us to treat more patients who otherwise would not have had access to biologics, which I think is a very good thing.
What challenges do you see arising with patient acceptance as biosimilars become more widely available? How do you anticipate addressing these issues? Please leave a comment below.
Then, get your questions regarding biosimilars answered by visiting our frequently asked questions module that address some of the most common questions regarding biosimilars.