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Considerations for Biosimilar Adoption in Pediatrics: A Scoping Review
Elaine Lau1,2,3, Alicia Koo1, Han Byul Kang1
1Department of Pharmacy, Hospital for Sick Children, 555 University Ave, Toronto, ON, Canada, M5G 1X8.
Pharmaceutical Medicine
|December 1, 2025
Summary
Limited clinical evidence hinders biosimilar uptake in children. More pediatric studies and pharmacovigilance are needed to build confidence and guide healthcare institutions in adopting biosimilars for pediatric patients.
Area of Science:
- Pharmacology and Therapeutics
- Health Services Research
- Pediatric Medicine
Background:
- Biosimilar adoption in pediatrics lags behind adults due to limited clinical evidence and safety/efficacy uncertainties.
- Patent expirations of biologics create opportunities for biosimilar market expansion.
- This review addresses the need for evidence to inform pediatric healthcare institutions on biosimilar decision-making.
Purpose of the Study:
- To identify themes influencing biosimilar adoption in pediatric healthcare settings.
- To inform decision-making processes for pediatric institutions regarding biosimilar use.
- To develop a policy framework for pediatric biosimilar adoption.
Main Methods:
- Scoping review of academic and grey literature from inception to September 20, 2024.
- Searches included OVID Medline, Embase, International Pharmaceutical Abstracts, and regulatory/HTA agency websites.
- Included studies focused on pediatric biosimilar use and institutional decision-making; excluded non-English, industry-focused, or solely adult-indication studies.
Main Results:
- 35 articles were included (26 pediatric-specific).
- 14 themes emerged, categorized into substantive (evidence, cost, safety, dosage forms) and procedural (approval, interchangeability, education, monitoring) principles.
- Themes informed a policy framework for pediatric biosimilar adoption.
Conclusions:
- A significant health-system gap exists in pediatric biosimilar adoption.
- Industry needs to conduct robust pediatric efficacy and safety studies pre-market.
- Enhanced pharmacovigilance and patient registries are crucial for generating real-world evidence and building confidence.
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