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Unmet Needs With Biosimilars


Expert rheumatologist and dermatologist, Drs Roy M. Fleischmann and Joel M. Gelfand discuss unmet needs in biosimilars.

Roy M. Fleischmann, MD: Joel, from our discussion, there were 2 unmet needs. One is extrapolation. You’d like to see data on each of the biosimilars in each of the diseases showing that they’re good for extrapolation. Is that correct?

Joel M. Gelfand, MD, MSCE, FAAD: From my perspective, absolutely. That’s ultimately the highest-level data that you want to see, and it will be useful for further instilling confidence in the therapies you’re going to perform, especially when we get into real-world patients.

Roy M. Fleischmann, MD: The other question that we touched on is regarding interchangeabilities. I’ve seen several of interchangeability studies, and they look really good, where they talk about going from the biosimilar to the reference product, from the reference product to the biosimilar to the reference product, and people staying on the reference product or staying on the biosimilar. They all look the same. What do you think about the real possibility, the patient reference product, biosimilar 1, biosimilar 2, biosimilar 3, the reference product, biosimilar 2, biosimilar 1, biosimilar 3? Do you have concerns about that?

Joel M. Gelfand, MD, MSCE, FAAD: We’ll have to have some additional observational studies for these things to ensure that what we’ve seen in the clinical trials, which are fairly highly selected patient populations and relatively short-term studies, extrapolate into more real-world settings. As you mentioned earlier in our discussion, if a patient is a 40-year-old woman who may be morbidly obese, has other health issues going on, and has previously lost response to a couple of biologics, are they going to have the same experience as someone who may be younger, healthier, and is starting their first biologic for their disease? Those are some of the nuances that we probably want more data on as this field grows and expands.

Roy M. Fleischmann, MD: Yes. I can answer your question about the patient who’s older, obese, several medications have failed, and has more comorbidities vs the younger patient who’s treatment naïve. The answer is: yes, the person who’s treatment naive and younger without the comorbidities will do better. I’ll guarantee it 99% of the time.

In terms of studies, I have a good friend who’s in Manchester, UK. We get together a couple of times of year. We talk about biosimilars because they have great experience with biosimilars. Years ago, we talked about whether going from a reference to a bio-original is problematic. He told me that he was forced to do that for the National Health Service and it wasn’t problematic. Then I asked, “What about going to a second biosimilar?” He said, “We do it occasionally.”

The last time I saw him, which was a month ago, he reminded me of that conversation. We were talking about etanercept. For reference, etanercept is dirt cheap in the UK. The price has gone way down because it’s a single-payer system. He said, “You asked about switching.” A couple of years ago, he said they’d switch every year or 6 months. It’s now the etanercept of the week. It’s switched every week. Anecdotally, he says that it isn’t problematic. It’s anecdotal, but if you get enough anecdotal stories from physicians rather than from social media, you can pretty much rely on those results.

Transcript Edited for Clarity

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