Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses the challenges of expanding biosimilars into new therapeutic areas and highlights the role of education, competitive pricing, and integrated delivery networks in improving adoption and market growth.
Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses the challenges of expanding biosimilars into new therapeutic areas and highlights the role of education, competitive pricing, and integrated delivery networks (IDNs) in improving adoption and market growth.
Recently, Humphreys was a cochair at The American Journal of Managed Care®’s Institute for Value-Based Medicine (IVBM) event in Seattle, Washington, cohosted with Providence. During the event, she presented on pharmacoeconomic impacts of biosimilar market expansion and participated in a panel discussion. The IVBM event highlighted integrative approaches in neuroscience population health, with additional presentations on the Alzheimer disease landscape, nonopioid pain management, and the impact of biosimilar market expansion.
This interview was edited for clarity.
How do new therapeutic classes and indications for biosimilars influence market expansion?
Humphreys: I think this goes beyond just patient education. For example, when we started with biosimilars for cancer—curative and supportive agents—they were quickly adopted. But once we moved into immunology, endocrinology, and ophthalmology, we observed more hesitation. One reason is that many of these are maintenance therapies. We’re not talking about starting a new treatment plan but convincing patients who may have already failed several therapies before reaching the [reference] biologic to switch to a biosimilar.
So, first, we needed to educate both patients and providers that biosimilars are highly similar to the reference product. There's no evidence of reduced efficacy, increased immunogenicity, or new safety concerns. Over the past 10 years, we’ve used biosimilars successfully. We also needed to address health care system leaders that expanding biosimilar use across therapeutic classes can increase access to lifesaving, life-altering medications for more patients.
What are the key factors driving competition among adalimumab biosimilars in the market?
Humphreys: Adalimumab has been a favorite molecule since July 2023, and several factors play a role. It’s quite similar to what we saw with infliximab in autoimmune diseases. Many of these patients are on maintenance treatments. With adalimumab, a key issue is matching the existing product patients are used to. For example, if my patient is using a citrate-free product, you probably don’t want to switch them to a product that isn’t citrate-free, as that could cause more injection-site discomfort. Another consideration is concentration—many patients prefer a higher-concentration formulation.
Interchangeability is also a factor. In states that allow pharmacy-level switching, when a physician prescribes the reference product, a pharmacist can switch it to an interchangeable biosimilar without new authorization. Each state has its own regulations, including the need to inform patients and physicians about the switch. Lastly, we have to ensure the biosimilar is covered by the patient's payer and offers comparable patient support, such as co-pay assistance. For 340B sites, the impact on 340B accumulation must also be considered. These are comprehensive considerations.
What pricing strategies have been employed in the adalimumab biosimilar market, and how effective have they been?
Humphreys: That’s a $20 billion question. By the end of 2023, we saw 2 main strategies: high WAC [wholesale acquisition cost] with high rebates and low WAC. Almost all biosimilar companies have adopted 1 [or both] of these strategies.
Unfortunately, by the end of 2023, according to IQVIA’s biosimilar report, we hadn’t seen a high adoption rate—less than 5%. However, when infliximab was introduced, its first-year uptake didn’t exceed 5% either. So, while it’s early, we’re already seeing a benefit as [reference] products reduce prices due to competitive pressure. In my view, biosimilars delivered a win to both the health care industry and patients in 2023.
How does the adalimumab biosimilar market serve as a case study for the broader biosimilar industry?
Humphreys: Time will tell. Adalimumab biosimilars are working hard to promote their products, engage with payers, and connect with patient groups. I hope that in 2 or 3 years, we’ll be able to differentiate which product strategies were more effective—whether interchangeability made a difference, whether high-concentration vs low-concentration mattered, and if syringe size or citrate-free options enhanced adoption. For now, we’re still in the learning phase.
What lessons can be learned from markets with high biosimilar adoption rates to improve uptake in slower markets?
Humphreys: That’s a great question. First, we need to differentiate between medical benefit and pharmacy benefit. Many of the most successful biosimilars are in the medical benefit space, especially in the "buy and bill" space. IDNs that work closely with GPOs [group purchasing organizations], 340B branches, and formulary management teams perform regular reviews of coverage, patient mix, and ASP vs acquisition cost. This helps them decide which biosimilars to prioritize. Additionally, some IDNs have built biosimilar tools into their EHR [electronic health record] systems to streamline physician workflows. Physicians are extremely busy and can’t be expected to remember which product to use each quarter, so it’s important to build support into the system. Some IDNs have also incorporated prior authorization processes for both the reference product and biosimilars, further streamlining care. Finally, it’s crucial to conduct regular performance reviews and share success metrics with leadership. This continuous improvement process elevates the entire system.
How have early adopters of biosimilars influenced the overall acceptance of these products?
Humphreys: Early on, systems like Kaiser Permanente, Providence, Yale New Haven, and University Hospitals published data on the success of their biosimilar programs. This real-world evidence from large IDNs across different therapeutic classes has shown several common success factors, such as starting early and conducting comprehensive pharmacoeconomic analysis. Smaller and rural hospitals, which may lack the resources of larger systems, can learn from these pioneers. Early adopters carry the initial resistance, but they also pave the way for the rest of the market to follow.
What strategies should IDNs employ to effectively incorporate biosimilars into their formularies?
Humphreys: IDNs should stay ahead of the game by closely monitoring FDA approvals and evaluating biosimilars as soon as they are approved. This supports contracting teams when negotiating with GPOs or biosimilar manufacturers, allowing them to promise market share in exchange for beneficial contracts.
Collaboration with payers is also crucial. And ArchMed has published its data showing that its biosimilar-first policy significantly reduced PMPM [per-member per-month] costs. These strategies help harvest the cost-saving potential of biosimilars for both health care systems and patients.
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