Cyltezo Biosimilar Now Available in United States

Boehringer Ingelheim announced on July 1 that its adalimumab (Humira) biosimilar, adalimumab-adbm (Cyltezo) is now commercially available in the US.¹ Cyltezo is the first and only adalimumab interchangeable biosimilar approved by the FDA. Cyltezo was first approved by the FDA in 2017 and was granted interchangeability designation in 2021. As of July 1, Cyltezo is available as a prefilled syringe or an autoinjector pen. Cyltezo is the only adalimumab biosimilar with phase 3 comparative clinical studies in rheumatoid arthritis, plaque psoriasis, and Crohn’s disease. VOLTAIRE-X (NCT03210259) evaluated the effects of multiple switches between Humira and Cyltezo compared to continuous treatment with Humira.

Cyltezo is approved for the treatment of moderate to severe Crohn’s disease, moderate to severe ulcerative colitis, moderate to severe chronic plaque psoriasis, and reduces the signs and symptoms of moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and moderate to severe hidradenitis suppurativa.

To capture the importance of today’s launch, Drug Topics' sister publication Dermatology Times® spoke with Dorothy McCabe, PhD, FCP, the executive director of biosimilars at Boehringer Ingelheim.

Q: Can you please provide an overview of Cyltezo for physicians who may be unfamiliar with it or biosimilars in general?

McCabe: Following its initial 2017 US Food and Drug Administration approval and its 2021 Interchangeability designation approval, Cyltezo (adalimumab–adbm), our biosimilar to Humira, is now commercially available, expanding treatment options for multiple chronic inflammatory diseases. Cyltezo, which is manufactured in the US, is approved as a citrate-free formulation that is currently available as a 40 mg/0.8 mL, 20 mg/0.4 mL, and 10 mg/0.2 mL prefilled syringe and as a 40 mg/0.8 mL prefilled autoinjector called the Cyltezo Pen. 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.

Taking a step back, 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. Biosimilars were established to provide more treatment options, increase patient access, and lower health care costs. Unlike small molecule drugs that are chemically synthesized and can be copied exactly in the form of a generic, biologics and biosimilars consist of large complex molecules that are manufactured using living cells, extracted, and purified. Since biologics are grown from living organisms, it is not possible to develop an identical copy of the original product, also known as a reference product. This applies to both batch-to-batch manufacturing of the same brand name biologic and to creating a biosimilar or Interchangeable biosimilar. This variation is normal and expected in all biologics manufacturing, which is different from small molecule chemical synthesis. Since biosimilars must demonstrate that they work in the same way as a reference biologic, patients can expect no clinically meaningful differences in therapeutic effect.

Q: How has Cyltezo reached interchangeability designation?

McCabe: Cyltezo is the first and only approved Interchangeable biosimilar to Humira. 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.

Q: What is the potential role of biosimilars in improving the sustainability of the US health care system?

McCabe: The complexity of biologic medicines makes them expensive to produce, placing a high cost on the health care system. The utilization of high-quality, lower cost biosimilars may improve the sustainability of health care systems, providing the potential for more patients to benefit from biologic medicines. The Pacific Research Institute estimates that biosimilar competition generates $11.2 billion in savings annually, and that Humira biosimilars could generate $5 billion in savings compared with current costs once biosimilars gain 75% of market share. Additionally, a recent report conducted by the Office of Inspector General (OIG) found that with increased use of biosimilars, rather than reference products, Part D and beneficiary spending could have been considerably reduced.

Q: How do you hope to see Cyltezo change the way more severe conditions are treated, such as hidradenitis suppurativa?

McCabe: As a leading research-driven biopharmaceutical company, we put patients first in everything we do. Biologics have transformed the treatment of many life-limiting diseases, but with the significant burden of disease, health care 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.

Biosimilars were established to provide more treatment options, increase patient access, and lower healthcare costs. We’re confident in the value that Cyltezo brings to the healthcare and patient communities, backed by a strong efficacy-safety profile established in clinical trials. By nature of being 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.

Q: What do you want dermatology providers to know about prescribing biosimilars who may not be comfortable/familiar yet?

McCabe: 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."

For more information, visit www.boehringer-ingelheim.us.

Dorothy (Dottie) McCabe, PhD, FCP, is currently the executive director of clinical development and medical affairs at Boehringer Ingelheim overseeing the biosimilar programs. She received a PhD in pharmacology from the University of Medicine and Dentistry of New Jersey and is a fellow with the American Academy of Clinical Pharmacology.

McCabe has thirty years of industry experience with broad multidisciplinary science and medicines expertise. She has held leadership positions in both medical affairs and clinical product development at a variety of medium and large pharmaceutical companies.

Focusing on immunology and biologic therapy since 1995, McCabe has led development teams investigating several compounds which have resulted in commercial success. Her professional interest is rheumatologic disease, specifically rheumatoid arthritis, and systemic lupus erythematosus.

Reference

1. Cyltezo, first and only FDA-approved interchangeable biosimilar to Humira, now commercially available in the US. Boehringer Ingelheim. July 1, 2023. Accessed July 1, 2023. https://www.boehringer-ingelheim.com/us/press-releases/interchangeable-biosimilar-now-available-us