Advancing Access to Affordable Treatment: The US Launch of Adalimumab-adbm


Stephen Pagnotta, executive director and Biosimilar commercial lead at Boehringer Ingelheim, discusses the significance of the US launch of biosimilar adalimumab-adbm and its interchangeable designation.

On July 1, 2023, adalimumab-adbm (Cyltezo®), the only US Food and Drug Administration (FDA)-approved Interchangeable biosimilar to adalimumab (Humira®), became commercially available in the US. The launch was an important step in expanding access to more affordable treatment options for patients living with a variety of inflammatory conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease. In an interview with HCPLive Rheumatology, Stephen Pagnotta, executive director and Biosimilar commercial lead at Boehringer Ingelheim, discusses the importance of this availability, the significance of an interchangeable designation, and the next steps for his team.

Advancing Access to Affordable Treatment: The US Launch of Adalimumab-adbm

Stephen Pagnotta

Credit: Boehringer Ingelheim

What does the recent commercial availability of adalimumab-adbm mean for both patients with autoimmune disease living in the US and their physicians?

It’s important to note that biologics have transformed the treatment of many life-limiting diseases, but with the significant burden of disease, healthcare systems are continuing to face a financial challenge to meet the needs of patients. As one of the largest producers of biologic medicines in the world, Boehringer Ingelheim hopes to increase the availability of safe, effective, high-quality therapeutic options to patients worldwide.

A biosimilar is a biologic medicine that is developed to be highly similar to an approved reference biologic, with no clinically meaningful differences in terms of safety, potency, and purity. The utilization of high‐quality, lower cost biosimilars may improve the sustainability of healthcare systems, providing the potential for more patients to benefit from biologic medicines.

We’re confident in the value that Cyltezo, our biosimilar to Humira, brings to the healthcare and patient communities, backed by a strong efficacy-safety profile established in clinical trials. As the first and only FDA-approved interchangeable adalimumab biosimilar, patients can expect the same therapeutic effect from Cyltezo as they can from its reference product, Humira.

Can you tell me a bit about the VOLTAIRE-X comparative clinical trial?

The efficacy and safety of Cyltezo are supported by a large body of data, including the phase 3 randomized VOLTAIRE-X clinical trial, which studied the effects of multiple switches between Humira and Cyltezo. The results of VOLTAIRE-X were presented at the 2021 American Academy of Dermatology Annual Meeting. Pharmacokinetic equivalence was demonstrated, with highly similar efficacy and immunogenicity, and comparable safety observed in patients who received either Humira continuously or who switched between Humira and Cyltezo.

Why is an interchangeable designation significant?

An interchangeable biosimilar first must meet the high FDA standards of a biosimilar. Then, to achieve the interchangeable designation, the FDA requires additional data, which may include a study of multiple substitutions in patients, known as a switching study. A switching study shows how patients do when they are switched back and forth from a reference product to the biosimilar. The switching study must show that patients can be switched with no increased risk in terms of safety or diminished efficacy, as compared to remaining on the reference product. According to the FDA, prescribers and patients “can expect that the interchangeable product will have the same clinical result as the reference product in any given patient.” And they “can be confident in the safety and effectiveness of an interchangeable product, just as they would be for an FDA-approved reference product.”

From our perspective, as a leading research-driven biopharmaceutical company, we put patients first in everything we do. A biosimilar with an interchangeable designation can be auto-substituted for the reference product by a pharmacist. Pharmacist-mediated auto-substitution could mean fewer administrative hurdles, which can potentially help patients get their medications faster than they would get non-interchangeable biosimilars. Individual state laws control how and whether providers and patients must be notified; nearly all states and Puerto Rico have enacted laws that allow pharmacists to substitute an interchangeable biological product without pre-notification to the prescriber.

What are the next steps for your team?

Moving forward, we will continue to focus on our key differentiators for Cyltezo: interchangeability, our broad data package (as the only adalimumab biosimilar with phase 3 comparative clinical studies in rheumatoid arthritis, plaque psoriasis, and Crohn’s disease), and our 37+ years of experience in biologic manufacturing.

We recently announced that Optum Rx, a pharmacy benefit manager (PBM) and subsidiary of UnitedHealth Group, will place Cyltezo on its commercial formulary as a preferred brand, which covers more than 66 million members. We will continue to work with insurers, payors, and PBMs to ensure access for as many people who need it as possible.

Is there anything else you’d like our audience to know?

We believe that value extends beyond the product. We collaborate with the FDA, healthcare systems, payors, and patients to develop policies and programs that provide healthcare providers and patients with continuity of care and a high level of confidence in biosimilars. We are dedicated to improving the lives of patients by promoting the use of biosimilars to expand overall treatment options and contribute to the quality and sustainability of the US healthcare system.

We understand the challenges that some patients may face in affording medication and strive to ensure our products are accessible to all. For patients, we have the Cyltezo Patient Support Program through BI Solutions Plus, which may help eligible patients with commercial insurance, including health insurance exchanges, federal employee plans, or state employee plans, pay as little as $0 per fill for Cyltezo. The patient support program also offers patients one-on-one personalized support to start and stay on Cyltezo, a dedicated Clinical Educator, and a dedicated insurance specialist who can provide support by verifying patients’ coverage for Cyltezo, determining utilization management requirements, and assist in navigating any required prior authorization process.

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