Expert Reviews Upcoming Approvals, Trends in Biosimilars

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Jensen notes that although she expects there will be a lot of FDA approvals in 2023 and 2024, there likely will not be another biosimilar “boom” until 2025.

Chelsee Jensen, PharmD, BCPS is the Senior Pharmacy Specialist and Pharmaceutical Formulary Manager at Mayo Clinic. Jensen joins Pharmacy Times at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 Conference (October 16 through October 19) in Orlando, Florida, to discuss biosimilars and what health care professionals can expect in the future.

Pharmacy Times: What is the current landscape for biosimilars? What can pharmacists expect from the coming year?

Chelsee Jensen: The biosimilar market continues to expand, we continue to see FDA approvals, and we have a lot of hot movement in adalimumab right now. However, I would say based on some IPD predictions and patent protections, we probably aren't going to see another big biosimilar boom until that year 2025 where we'll see more competitors actually entering the market. So, I think we'll see a lot of FDA approvals in 2023 and 2024, but potentially more delayed market entrance out until 2025.

Pharmacy Times: What are some biosimilar launch dates pharmacists should keep an eye on in 2024?

Jensen: For 2024, I would say the biosimilars to watch for will be the pegfilgrastim on-body biosimilar because, again, we know that the pegfilgrastim reference product is maintaining market share because of that on-body formulation, so, I think that's definitely 1 to watch in the next year to see does it get approval, can we start onboarding it, and again, 340B site implications as well.

Eculizumab is another 1 to watch, we could see an approval for that coming in 2024 that may impact our transplant practices where we know we have a heavy Medicare population, so potentially to reduce the costs for transplant practices as well as to see how it impacts use of ravulizumab, which is the longer-acting formulation that's dosed every 8 weeks. So, will we start seeing payers push patients to use the eculizumab biosimilar and potentially see some erosion from that ravulizumab reference product.

Pharmacy Times: What are current clinical considerations and gaps in research that are important for pharmacists to keep in mind when switching a reference product and a biosimilar?

Jensen: Well, there was just a great study that AJMC actually covered by Thomas Herndon and colleagues—this is what came out of the FDA as well as published in PLOS ONE—and again, [it was] a very robust meta-analysis evaluating over 5225 patients and this looked at etanercept, adalimumab, rituximab, infliximab—several biosimilars, I'm gonna miss them, but regardless—it found that there was no difference in adverse effects in discontinuation rates and deaths or in immunogenicity. So, I think that the real-world evidence is really growing and the FDA is also taking this into consideration when they're doing various work from a regulatory standpoint.

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