Dupixent (dupilumab) is a biologic medication used to treat a range of inflammatory conditions. Biosimilar versions of Dupixent are in development.
What conditions does Dupixent treat?
Dupixent is approved for moderate-to-severe atopic dermatitis in patients aged six months and older whose disease is not adequately controlled with topical therapies or when those therapies are not advisable. It is also used for moderate-to-severe asthma in patients aged six years and older whose asthma is not controlled with oral or inhaled corticosteroids. Additionally, it is indicated for chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults with moderate-to-severe CRSwNP whose disease is not adequately controlled with intranasal corticosteroids, and for prurigo nodularis in adults. [1]
How do biosimilar drugs work?
Biosimilars are biological products that are highly similar to an already approved reference product, known as a biologic. They are approved based on a demonstration of no clinically meaningful differences in terms of safety, purity, and potency (effectiveness) compared to the reference product. [2]
When might biosimilar Dupixent become available?
The timeline for the availability of biosimilar Dupixent depends on patent expirations and regulatory approvals. DrugPatentWatch.com tracks patent information, which can indicate when exclusivity for a drug may end. [3]
Who is developing biosimilar versions of Dupixent?
Several pharmaceutical companies are reportedly developing biosimilar versions of dupilumab. These include Amgen and Sanofi, the originator of Dupixent, which has its own biosimilar development programs. [4]
What is the difference between a biosimilar and a generic drug?
Generic drugs are typically simpler chemical compounds and are exact copies of brand-name drugs. Biosimilars, on the other hand, are complex molecules derived from living organisms. While biosimilars are highly similar to their reference biologic, they are not exact copies. The U.S. Food and Drug Administration (FDA) uses the term "interchangeable biosimilar" for products that can be substituted for the reference product by a pharmacist without the intervention of the healthcare provider. [2]