Challenges With Biosimilars Being Approved in the US

EP: 1.What are Biologics and Biosimilars, and How Are They Devolved?

EP: 2.Difference Between Biosimilars and Reference Product

EP: 3.Differences Between Biosimilars and Generic Drugs

EP: 4.Defining Key Terms Associated With Biosimilars

EP: 5.Defining Extrapolation

EP: 6.Defining Interchangeability Status

EP: 7.Unmet Needs With Biosimilars

EP: 8.Impact of Biosimilars on Payers, Health Care System, and Patients

EP: 9.Role of Biosimilars and Assessing Clinical Impact

EP: 10.How to Switch Patients to Biosimilars

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EP: 11.Challenges With Biosimilars Being Approved in the US

EP: 12.Clinician Confidence in Biosimilars

EP: 13.Addressing Patients' Concerns With Biosimilars

Joel M. Gelfand, MD, MSCE, FAAD: It’s worthwhile to ask, why is it taking so long to get biosimilars in the United States? A lot of it is because of patent lawsuits, is it not? What’s going on? Why are biosimilars available in Europe but take so long to have these approved in the US market?

Roy M. Fleischmann, MD: There are 2 parts of it. You’re exactly right about 1 part of it. The United States produces great things. We’re really good in technology and in medicine, and we produce a lot of lawyers. There are a lot of patent suits. Why would a company that has a reference product fight against the biosimilar? Morally and ethically, why would they fight against it? It’s all financial. If their drug is bringing in $15 billion a year, they want to keep making $15 billion a year.

There’s a second part of this equation, which you brought up before. That was the biosimilar for infliximab. There are 2 approved. They’re identical. The 2 biosimilars are the same molecule with different names. It’s had no uptake, and the reason is the PBM [pharmacy benefit manager]. The PBM is the middleman. The PBM has been the middleman between the insurance company and the patient, and all they do is [seek] profit. With the manufacturers, they say “We can use bio-original infliximab, and from that company, we get the rebate.” I referred to that before. A rebate is where they get X millions of dollars for using infliximab, and then they probably get a discount on the cost. The biosimilar comes in and says, “We’ll discount the cost more,” and the PBM says, “But what about that rebate? We want those millions in rebate.”

We have an infusion center in our practice. When we try to get the biosimilar, we’re told by the insurance company, “No, you have to use the bio-original.” It’s because of that rebate. There are 2 parts of this. Once the biosimilars are more available, once those patents have expired—for adalimumab, it’s going to be in the next year or two—what are the PBMs going to do? Are they going to have you use a biosimilar rather than the bio-original? It will depend on the rebate and the discount from the reference manufacturer. We have a strange system in the United States. Whether you’re ultra-right or ultra-left or in the middle,everybody will agree that it’s a strange system.

Joel M. Gelfand, MD, MSCE, FAAD: Yes. As you mentioned earlier, it’s going to vary based on the state you practice in. It’s going to vary based on the patient’s insurance and whether they’re dealing with a particular PBM. The clinician is going to see a lot of variation in their practice unless they’re practicing in a Kaiser setting or an HMO [health maintenance organization]–type setting where everything is internal. Our colleagues are prepared for the variation that’s coming our way.

Roy M. Fleischmann, MD: You bring up a really good point. You have the Kaiser system, where they’re the system. They’re the payer. My guess is they’ll use the cheapest version of adalimumab that’s been approved by the FDA. If you have interchangeability, they’ll switch it week by week depending on what’s cheapest.

In a way, there’s a reason to have confidence in a biologic that has been shown to be interchangeable, because they’ve gone through all those data that I talked about before. They’ve shown you can go from the reference to the interchangeable to the reference, and it doesn’t make any difference in terms of PK [pharmacokinetic] or PD [pharmacodynamic] effects whether you stay on the bio-original or biosimilar. Showing interchangeability is a good benefit. But in regard to the value of the interchangeability, unless it’s cheaper to the patient or their insurance cost comes down, there’s no value to the patient. It’s value to the insurance industry.

Joel M. Gelfand, MD, MSCE, FAAD: Right. And they all experience the anxiety around having to inject the medication a different way, or potentially a different sensation when they inject the medication if it’s a buffered product or not a buffered product. Even under the best of circumstances, where their reaction in their joints, skin, or gut should be the same, their experience of administering the product will vary. That’s likely to result in some conversations with their clinicians.

Transcript edited for clarity