Dupilumab, marketed as Dupixent, is a biologic drug. As of early 2024, there is no approved biosimilar for dupilumab in the United States [1]. The FDA Purple Book lists approved drugs and their licensing, including biosimilar approvals. However, no dupilumab biosimilar has yet been approved and listed in the Purple Book [1].
When could a dupilumab biosimilar be approved?
The timeline for biosimilar approval depends on several factors, including when patent protections expire and when a manufacturer submits a biosimilar application. For dupilumab, key patents are expected to expire in the coming years. DrugPatentWatch.com indicates that the earliest patent expiry for dupilumab is anticipated in 2026, with later expiries extending through 2037 [2]. A biosimilar manufacturer would typically wait until some of these exclusivity periods have ended before seeking FDA approval.
What is the difference between a biosimilar and a biologic?
A biosimilar is a biological product that is highly similar to an already approved biological medicine (the reference product) and has no clinically meaningful differences in terms of safety, purity, and potency. Biosimilars are approved by the FDA through a rigorous review process [3].
What companies are developing dupilumab biosimilars?
Several companies are reportedly working on developing biosimilars for dupilumab. These include Amgen, Samsung Bioepis, and Organon [4][5]. These companies would need to conduct analytical, preclinical, and clinical studies to demonstrate biosimilarity before seeking FDA approval.
What is the significance of patent expiry for biologic drugs?
Patent expiry for biologic drugs like dupilumab is crucial for the potential introduction of biosimilars. Once primary patents and market exclusivity periods expire, other companies can seek approval to market their biosimilar versions. This can potentially lead to increased competition and lower drug prices for patients [2].
How does the FDA approve biosimilars?
The FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) review biosimilar applications. The review process ensures that the biosimilar meets the same standards of safety and efficacy as the reference biologic [3].
What are the potential benefits of dupilumab biosimilars?
The introduction of biosimilars for biologic drugs like dupilumab can offer several benefits. These include increased treatment options for patients and potentially reduced healthcare costs due to competition.
What is the FDA Purple Book?
The FDA's Purple Book, officially titled "Lists of Licensed FDA-Approved Prescription Drug Products with Therapeutic Equivalence Evaluations," provides information on approved drugs, including biologics and their biosimilar or interchangeable versions. It serves as a reference for the availability of these products [1].
What is dupilumab used to treat?
Dupilumab (Dupixent) is a monoclonal antibody used to treat moderate-to-severe atopic dermatitis, asthma, and other inflammatory conditions [6].
Sources:
[1] FDA.gov
[2] DrugPatentWatch.com
[3] FDA.gov
[4] Fierce Pharma
[5] Biosimilars Asia
[6] Dupixent.com