The U.S. Food and Drug Administration (FDA) Orange Book lists approved drugs, including those with approved biosimilar or interchangeable versions [1]. As of now, there are no approved biosimilar or interchangeable versions of dupilumab listed in the FDA's Orange Book [2].
What is the difference between a biosimilar and an interchangeable biosimilar?
A biosimilar is a biological product that is highly similar to a reference product and has no clinically meaningful differences in terms of safety, purity, and potency. An interchangeable biosimilar, in addition to meeting biosimilar standards, can be substituted for the reference product by a pharmacist without the intervention of the prescribing healthcare provider [3].
When might dupilumab biosimilars become available?
The availability of biosimilars for dupilumab depends on patent expirations and any subsequent legal challenges or settlements. Information on patent exclusivity for drugs can be found on resources like DrugPatentWatch.com [4].
What is dupilumab used to treat?
Dupilumab is a biologic medication used to treat moderate-to-severe atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps [5]. It works by blocking specific proteins in the immune system that contribute to inflammation [6].
Who makes the original dupilumab drug?
The original dupilumab drug, marketed as Dupixent, is manufactured by Sanofi and Regeneron Pharmaceuticals [7].
Are there any drugs similar to dupilumab?
Dupilumab is a monoclonal antibody that targets the IL-4 and IL-13 pathways. Other biologic therapies exist for the conditions dupilumab treats, but they may target different pathways or have different mechanisms of action [8].