Abstract
ABSTRACT
Background and Aims
The integration of biosimilars into pediatric healthcare represents a significant evolution in treatment accessibility and cost‐effectiveness. Biosimilars—biological products highly similar to already approved biologics, have emerged as promising alternatives for managing chronic and rare pediatric conditions, including inflammatory bowel disease, juvenile idiopathic arthritis, psoriasis, asthma, lupus nephritis, and growth hormone deficiencies. Despite regulatory, clinical, and societal challenges, current data suggest biosimilars demonstrate comparable safety, efficacy, and immunogenicity profiles to their originator products. The review consolidates findings from recent clinical trials, real‐world data, and regulatory landscapes across the US and EU, emphasizing the growing role of biosimilars in pediatric pharmacotherapy. It also explores future directions in biosimilar development, highlighting the need for improved pediatric‐specific research, regulatory harmonization, and stakeholder education to ensure wider adoption and optimized outcomes in children.
Method
A structured literature search of PubMed, Scopus, Web of Science, and Google Scholar (2003–March 2026) identified English‐language studies on pediatric biosimilars. Relevant clinical, regulatory, and review articles were thematically synthesized.
Results
In pediatric patients with chronic conditions such as inflammatory bowel disease and rheumatologic disorders, biosimilars like infliximab and adalimumab offer efficacy and safety comparable to originator biologics, while lowering treatment costs. Economic analyses demonstrate that biosimilars are typically 15%–45% cheaper than reference products in Europe, and in some markets up to 85% lower, improving affordability and access to treatment in pediatric populations.
Conclusion
Biosimilars have a great deal of promise to improve therapeutic access and lower medical expenses associated with pediatric care. However, to maximize results and guarantee therapeutic fairness in pediatric medicine, broader adoption necessitates increased age‐specific clinical trials, harmonized regulations, better training for healthcare providers, and increased stakeholder trust.