Cyltezo Biosimilar launches today in the United States

Boehringer Ingelheim today announced that its biosimilar adalimumab (Humira; AbbVie) Cyltezo (adalimumab-adbm) is now commercially available in the United States.¹ Cyltezo is the first and only adalimumab interchangeable biosimilar approved by the US Food and Drug Administration (FDA). Cyltezo was first approved by the FDA in 2017 and received interchangeability designation in 2021. As of today, Cyltezo is available as a prefilled syringe or autoinjector pen. Cyltezo is the only adalimumab biosimilar with comparative Phase 3 clinical trials in rheumatoid arthritis, plaque psoriasis and Crohn’s disease. VOLTAIRE-X (NCT03210259) evaluated the effects of multiple switching 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 reduce the signs and symptoms of moderate to severe rheumatoid arthritis, – idiopathic arthritis severe polyarticular juvenile, psoriatic arthritis, ankylosing spondylitis, and moderate to severe hidradenitis suppurativa.

To capture the significance of today’s launch, Dermatology times spoke with Dorothy McCabe, PhD, FCP, executive director of biosimilars at Boehringer Ingelheim.

Q: Can you provide an overview of Cyltezo for clinicians who may not be familiar with it or for biosimilars in general?

McCabe: Following initial US Food and Drug Administration approval in 2017 and Interchangeability Designation approval in 2021, Cyltezo (adalimumabadbm), our biosimilar of Humira, is now commercially available, expanding treatment options for multiple diseases chronic inflammatory. Cyltezo, manufactured in the United States, is approved as a citrate-free formulation 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 prefilled syringe /0.8 mL mL prefilled autoinjector called Cyltezo Pen. As the first and only FDA-approved interchangeable adalimumab biosimilar, patients can expect the same therapeutic effect from Cyltezo as they can get from its reference product, Humira.

Stepping back, a biosimilar is a biological medicine developed to be very similar to an approved reference biologic, with no clinically meaningful differences in terms of safety, potency, and purity. Biosimilars were created to provide more treatment options, increase patient access and reduce healthcare costs. Unlike small molecule drugs that are chemically synthesized and can be copied exactly in the form of a generic, biological and biosimilar drugs are made up of large complex molecules that are made using living, extracted and purified cells. Since organic products 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 both to the batch-to-batch production of the same branded organic product and to the creation of a biosimilar or an interchangeable biosimilar. This variation is normal and expected in all biological product manufacturing, which is different from the chemical synthesis of small molecules. Because biosimilars must be shown to work in the same way as a reference biologic, patients cannot expect clinically meaningful differences in therapeutic effect.

Q: How did Cyltezo achieve the designation of interchangeability?

McCabe: Cyltezo is the first and only approved interchangeable biosimilar for Humira. The efficacy and safety of Cyltezo are supported by a large body of data, including the randomized Phase 3 clinical trial VOLTAIRE-X, which investigated the effects of multiple switching between Humira and Cyltezo. VOLTAIRE-X results 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 Humira continuously or who switched from Humira to Cyltezo.

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

McCabe: The complexity of biologics makes them expensive to produce, with a high cost to the healthcare system. The use of high-quality, low-cost biosimilars can improve the sustainability of healthcare systems, enabling more patients to benefit from biological medicines. The Pacific Research Institute estimates that biosimilars competition generates savings of $11.2 billion annually, and that Humira biosimilars could generate savings of $5 billion over current costs once biosimilars gain 75 % of market share. Additionally, a recent report 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 significantly reduced.

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

McCabe: As a leading research 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, healthcare systems continue to face a financial challenge in meeting patient needs. As one of the world’s largest producers of biologics, Boehringer Ingelheim hopes to increase the availability of safe, effective, high-quality treatment options to patients around the world.

Biosimilars were created to provide more treatment options, increase patient access and reduce healthcare costs. We are confident in the value Cyltezo brings to the patient and healthcare communities, supported 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 get from its reference product, Humira.

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

McCabe: An interchangeable biosimilar must first meet the high FDA standards of a biosimilar. So, to obtain the interchangeable designation, the FDA requires additional data, which may include a study of multiple substitutions in patients, known as a switching study. A switch study shows how patients behave when switching back and forth from a reference product to a biosimilar. The switch study should demonstrate that patients can be switched without an increase in safety risk or a decrease in efficacy compared to maintaining the reference product. According to the FDA, prescribers and patients can expect that the interchangeable product will have the same clinical outcome as the reference product in a given patient.” And “they can be confident in the safety and efficacy of an interchangeable product, just as they would be for an FDA-approved reference product.”

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

Author bio

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

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

Focusing on immunology and biologic therapy since 1995, Dr. McCabe has led development teams studying several compounds that have led to commercial success. His professional interest is rheumatologic disease, particularly rheumatoid arthritis and systemic lupus erythematosus.

Reference

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