WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim's Cyltezo as the first interchangeable biosimilar to AbbVie's top-selling drug Humira or adalimumab. Cyltezo, originally approved in August 2017, is both biosimilar to, and interchangeable with Humira for Cyltezo's approved uses.
Cyltezo is the first interchangeable monoclonal antibody and only the second interchangeable biosimilar product ever approved by the FDA. Meanwhile, the FDA has already approved 31 biosimilar products, including six biosimilars to Humira itself.
The regulatory approval for interchangeability was supported by positive data from Boehringer Ingelheim's Phase III randomized VOLTAIRE-X clinical trial. The data showed that interchanging several times between Cyltezo and Humira resulted in no meaningful clinical differences for pharmacokinetics, efficacy, immunogenicity, and safety.
Amgen's Amjevita will be the first Humira biosimilar to hit the market on January 31, 2023, while Cyltezo will hit the market in the U.S. only on July 1, 2023. Boehringer Ingelheim, along with five other Humira biosimilar maker's, settled with AbbVie for launch dates in 2023 due to patent protections. Biosimilars to Humira were launched in Europe in 2018 itself.
These types of biosimilar and interchangeable biosimilar products can help increase access to treatment options for patients with serious medical conditions. They may also cost less than the brand-name medicine.
Cyltezo, offered in a single-dose, pre-filled glass syringe of 40 mg/0.8 mL and 20 mg/0.4 mL, is administered subcutaneously (under the skin) under the guidance of a physician.
Cyltezo is already approved for moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis and moderate to severe chronic plaque psoriasis.
Cyltezo is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients two years of age and older, and pediatric patients six years of age or older with Crohn's disease.
A biosimilar is a biological product that is highly similar and has no clinically meaningful differences with an FDA approved biological product in terms of safety, potency and purity. Meanwhile, an interchangeable biosimilar or substitute product can be expected to produce the same clinical result as the reference product.
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