The Availability of Multiple Biosimilars for 1 Biologic



Lee Schwartzberg, MD, FACP: The marketplace will now provide us with multiple options. For trastuzumab biosimilars we have 5 that are approved, not yet 5 on the market, but several more will be coming to the market, or just have reached the market in the last couple of months. So how do you decide which 1 to use?

And like many other things, the marketplace will help decide, and it’ll be based on a constellation of factors. Number 1, the cost, and whatever the reimbursement scheme will be for a particular drug will be important. Number 2, the faith in the company and the way that they developed the drug, including the clinical trials. But I am comfortable having looked at the clinical data for all 5 of the trastuzumab biosimilars, although they use different reference populations, all highly sensitive for HER2 [human epidermal growth factor receptor 2]-positive breast cancer either in the early stage or in the metastatic setting. I think all the studies were conducted well. So, the clinical data I think are good for all of them. And then again, it’s thinking about the company that’s providing the drug, their reliability, the history, their experience with manufacturing biologicals and so forth.

One question that always arises is who should be making the decision about what drug to use, particularly if you have multiple versions of a drug that have not been compared 1 to each other, but at least each of them have been compared to the originator. The first article is the provider has to have comfort that he’s not doing the patient a disservice to give a biosimilar. I feel very comfortable. I think the weight of the data absolutely support that you can be confident every time. If a biosimilar is approved, you will get the same kind of results as you would with the originator.

The patient definitely has a say in this. In general, patients are very concerned about the cost of their care. It’s a tragedy that the most common reason for bankruptcy in the United States today is medical bills. And oncology, unfortunately, is one of the most expensive treatments out there. Every new drug that comes out now is over $100,000 a year—not sustainable. So faced with a proposal to a patient, “I have a drug that’s going to work just as well for you and it’s 30% less, which one do you want,” it’s pretty obvious if they’re comfortable that I’m comfortable with it, they’re going to pick the lower-cost drug. And we’ve seen that with generics for small molecules as well, and this shift to generics, as long as they’re made in a quality fashion too. So biosimilars follow that path.

Insurers, in general, biosimilars to me is a good situation where the value lines up pretty well for everybody. There’s not one group that’s going to benefit more than the other, so I think in general payers, providers, and patients are all aligned for using biosimilars. But occasionally, depending on the contract, a particular payer may want a drug that’s more expensive because they got it less expensive.

So, there can be conflicts, and it speaks to the complexity of the way drugs are reimbursed in the United States today. It’s something we’re living with and something that we’re trying to simplify and change.

We will be seeing many more biosimilars. The restriction on biosimilars to date is based on the patent laws for any originator drug. As they expire, we will see more and more biosimilars in the oncology space. The most biosimilars today are in the rheumatology space where biologicals are used very frequently across a lot of rheumatologic diseases, and they’ve been used for quite some time, so there’s much more experience there. And every drug that’s a biologic that expires in its patent will have reputable companies making biosimilars because it’s cheaper to develop than the originator molecule.

I think there are a couple of trends that may happen in the future. First of all, we now have antibody drug conjugates, which are the antibody like a trastuzumab with a drug combined to it. We have not yet seen, nor would we because no patents have expired yet on an ADC, or an antibody drug conjugate, but it’s possible we will have biosimilars in that realm in the next few years.

We will potentially see bio-betters, which is a regulatory defined group. So, it’s not similar. Remember, what we’ve been trying to do here is find a drug that’s not either better or worse, that works the same. So you take that 1, you can use this 1. Here you can develop, if you understand the biology and the manufacturing, potentially you could make a drug that works better.

So we might be seeing bio-betters come in the future as well, which would be a step up not only in value in terms of less cost for the same efficacy, but maybe less cost for more efficacy, and that would be an exciting development.

Biosimilars today are used for any of the indications. Biologics are sometimes used as single agents, but more frequently, particularly in HER2-positive breast cancer, they’re used in combination with chemotherapy. We’re already very comfortable with the combinations in the neoadjuvant/adjuvant setting. We use it with chemotherapy in the metastatic setting. Trastuzumab or trastuzumab biosimilar is used in combination with chemotherapy and then may also be used as maintenance therapy.

So we’re already very comfortable with either monotherapy use or a combination therapy use.

Transcript Edited for Clarity

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