Biosimilars in pediatrics.

Biosimilars are highly similar versions of already authorized biological drugs. A notable benefit of these is their significantly lower price compared to innovator drugs, which frees up healthcare resources and improves affordability. Leading regulatory agencies approve biosimilars after rigorous comparability studies, ensuring that there are no significant differences in quality, safety, and effectiveness. Currently, the structural and functional equivalence of biosimilars to originators may be sufficient evidence, together with post-marketing experience, to support their safe and effective use in pediatrics. Although the extrapolation of indications and interchangeability continues to be debated, research continues to support the use of biosimilars. However, challenges remain, such as regulatory heterogeneity and mistrust due to misinformation. Continuing education and clear public policies are essential to maximize their adoption and access to vulnerable populations such as children.