O'Regan Shares Insight on Biosimilar Revolution in Oncology


Ruth O’Regan, MD, shares her perspective on the use of biosimilars in breast cancer and their future in oncology.

Ruth O'Regan, MD

Biosimilars continue to emerge in oncology, leading to treatment options at significant discounts compared with their reference products, explained Ruth O’Regan, MD.

“A huge issue in this country and worldwide is that all of these drugs are so expensive. As a community, we need to find a way of dropping the price of these drugs. The data with the biosimilars show, very clearly, that they are similar in efficacy and toxicity of the parent drug,” said O’Regan. “If [biosimilars] are cheaper, we should use them.”

Currently, there are 5 trastuzumab (Herceptin) biosimilars with FDA-approved indications for patients with HER2-positive breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma: MYL-1401O (Ogivri; trastuzumab-dkst), CT-P6 (Herzuma; trastuzumab-pkrb), SB3 (Ontruzant; trastuzumab-dttb), PF-05280014 (Trazimera; trastuzumab-qyyp), and ABP 980 (Kanjinti; trastuzumab-anns).

A key initiative, O’Regan added, is that patients must be educated on biosimilars, as well, so that they understand the equivalency in efficacy between these agents and their reference products.

In an interview with OncLive, O’Regan, professor of medicine, Division of Hematology/Oncology, at University of Wisconsin School of Medicine and Public Health, associate director, Clinical Research, University of Wisconsin Carbone Cancer Center, shared her perspective on the use of biosimilars in breast cancer and their future in oncology.

OncLive: Trastuzumab biosimilars are becoming available in the clinic at a significant discount compared with their reference products. How will this impact treatment decisions?

O’Regan: This is going to be a key [change]. At the end of the day, we don't make the decisions on which drugs to use. It really comes down to the payers, and I imagine that the payers will be extremely interested in cheaper options.

Some of the existing companies have discounts [on original drugs], but they are not coming anywhere close to what the cost of the biosimilars are going to be. We have a capitated system [at University of Wisconsin Carbone Cancer Center], so we do what we're told in terms of what we utilize. [Biosimilars] are going to have a very profound effect.

What are the estimated cost differences between the original drugs and the biosimilars?

There are a lot of generic drugs available, but for trastuzumab [biosimilars] I had heard that they did [offer discounts]. At the end of the day, we need to look at the cost differences because one of the issues that comes up is whether patients are going to want to switch to [biosimilars]. If we have somebody with metastatic breast cancer who has been on trastuzumab for a while and is doing fine, they may be apprehensive to go on an alternative drug. However, we may have no option. We're in the process of developing educational information for the patients so that they understand these drugs are essentially the same.

How do you suggest physicians speak with patients about moving to a biosimilar?

The way I would introduce it is, “This is the same drug at a lower cost.” The issue will be whether there are any savings for the patient. There could be, but there also could not be, because these are intravenous formulations. We need to reiterate that these drugs have been tested and they look exactly the same as the parent drug. There is no reason to believe that they won't be just as effective.

[Using a biosimilar] is going to be much easier for patients with a new diagnosis; I think they will be more accepting because they have not been on the [original] drug. For patients with metastatic disease who are very dependent on these drugs and have been doing well, it may be a little trickier. I would imagine that we will also have our pharmacists come down and help reiterate that [biosimilars] are the same drug.

Experts say that insurance companies will eventually choose to cover certain biosimilars. How will this impact practice?

That's pretty much the way it is now. When drugs go generic, they do have some impact on that because, depending on what the cost is, [payers] will push back on that. If the biosimilars are all equal in efficacy with the same toxicity, I'm not sure it matters who makes the decision on which [biosimilar is chosen]. In the real world, as we get more experienced with these drugs, maybe there will be subtle differences that we don't know about.

Has there been any hesitation to use biosimilars?

I suspect some [oncologists will be hesitant] because they're used to [administering certain drugs]. However, we may not have any choice in this, and that's the bottom line. If that's what's being paid for, it's our job to make sure that patients are comfortable and that they know that this drug is the same as the other drug.

What is the current state of education and awareness surrounding biosimilars?

It's probably inadequate. Most of us have seen some data that suggest that [biosimilars] are equivalent; there is probably more work to be done with that. I'm pretty specialized [in breast cancer], so where it applies to me is with trastuzumab and some of the growth factors, which we have already been using. The growth factors are a very good example; they show that we don't have any choice [in what drugs we give our patients].

The insurance companies will only pay for whatever they pay for and [that is what we are given]. Our system, at the University of Wisconsin Carbone Cancer Center, is a little different because this is a capitated system. We have to stay within the guidelines of the payer. There's been no real pushback with regards to growth factors.

This is a totally different scenario, because [they are used in a more acute situation] rather than a life-saving drug, such as trastuzumab. I don't know what the community doctors know about this; I'm sure they probably know quite a bit. For me, I have seen the presentations on biosimilars that [payers] are ready to save [money]. It seems very reasonable. There will need to be some education [on biosimilars for physicians].

What organizations are working to raise more awareness and education efforts on biosimilars?

This is something that the National Comprehensive Cancer Network (NCCN) looks at pretty regularly to evaluate the value, efficacy, and toxicity. NCCN is pretty supportive; this organization actually had a meeting on biosimilars about 3 or 4 years ago. This is very much on their radar. What the NCCN recommends will impact what is being done on a national level.

What else should oncologists keep in mind about biosimilars?

Anything that saves money is definitely a good thing. I don't think there's going to be a huge amount of pushback on the physician side, but I don't know on the patient side. We really need to be very clear in our messaging to patients so they are not to worry. These drugs have been vetted to be the same as the parent drug. They should completely be of equal efficacy, and patients should not be losing out on anything by taking these biosimilars.

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