Biosimilars in allergology: an outline in pediatric patients

Biosimilars are increasingly shaping the management of pediatric allergic diseases and offering cost-effective alternatives to originator biology. This review summarizes the scientific and regulatory principles of biosimilars and examines the role of biosimilars in pediatric allergology, focusing on their clinical applications, opportunities, and challenges.

Biosimilars were developed through a stepwise comparability process, including analytical, pharmacokinetic, pharmacodynamic, and clinical evaluations, to ensure equivalence with reference products. Among pediatric allergies, biologics targeting type 2 inflammation have significantly improved outcomes in several diseases, including asthma, atopic dermatitis, chronic spontaneous urticaria, and food allergies. Omalizumab is currently the only biologic drug with an approved biosimilar that has demonstrated comparable efficacy, safety, and immunogenicity, even after switching. However, concerns remain regarding limited availability of long-term pediatric data.

Biosimilars represent a promising and sustainable opportunity to broaden access to advanced pediatric allergology therapies. Their integration into clinical practice, supported by growing evidence and appropriate clinical governance, has the potential to optimize treatment outcomes and improve long-term disease management. Further evidence on their risk-benefit profiles will help support their effective and informed use in the pediatric population.