Upcoming Drug Approvals Fill Unmet Needs in Nonalcoholic Steatohepatitis

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Biosimilars are also expanding rapidly, offering new opportunities for payers, patients, and providers.

In an interview with Pharmacy Times at the 2023 Asembia Specialty Pharmacy Summit, Ray Tancredi, MBA, divisional vice president of Specialty Pharmacy Development and Brand Rx/Vaccine Purchasing at Walgreens, discussed the new approvals that he’s looking forward to in 2023. Biosimilars are also expanding rapidly, offering new opportunities for payers, patients, and providers.

Q: What are some of the significant drug approvals that you are monitoring for the rest of the year?

Ray Tancredi, MBA: That's a great question. I you know, as you look at the pipeline, and it's full of medications, there is an unmet need in [nonalcoholic steatohepatitis] and there are a couple of drugs that are going to be approved in short order. The first one is Ocaliva; we'll probably see that approved sometime in June of this year, followed by Madrigal’s product resmetirom, which is going to be approved probably in September or maybe late August. These really meet an unmet need for patients. It's long awaited. I think that pharmacy directors, payers, and physicians and patients are really looking forward to this drug. I saw some information that it could be about a $3.2 billion space over the next few years, so we'll continue to see that grow. And you could see about 30 million patients on this drug. I think 5% to 6% of the people in the United States have NASH and 12% of those progress to cirrhosis, and the patients that have progressed to cirrhosis really have a tough disease on their hands. And so, these particular products will fit that unmet need and I look forward to seeing them approved.

Q: Biosimilars are rapidly hitting the market now. What kind of impact are they starting to have on costs, and what do you expect in the coming years?

Ray Tancredi, MBA: Yeah, you know, we've followed biosimilars for many years. Most of them have been covered on the medical side of the benefit like Remicade, Procrit, Herceptin. The exciting part is that probably the largest selling drug in the world and certainly in the United States, Humira, will now have biosimilars available. Amgen had their biosimilar approved in January, and we're looking for 5 to 6 more manufacturers to bring a biosimilar for Humira to market in July. Anytime you lower the sticker price of a product, which you're going to see with biosimilars, it'll bring savings to the marketplace. The payers have the ability to create formularies including the originator. We may see a formulary that consists of Humira plus maybe 2 or even 3 of the biosimilars. Some of those biosimilars could be interchangeable, which makes it easy for pharmacists to actually substitute when necessary. So, it's really an exciting place. I think it will bring savings; it's yet to be determined. But even more exciting on the horizon, you have products like Stelara, Prolia, and even Tysabri that will have biosimilars. So, the specialty pharmacy landscape continues to evolve, giving the patients, physicians, payers, and PBMs choices of products.

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