Biosimilars in Adult and Pediatric Noninfectious Uveitis

Area of Science:

• Ophthalmology
• Immunology
• Pharmacology

Background:

• Noninfectious uveitis (NIU) is a group of inflammatory eye conditions requiring long-term management.
• Biologic therapies, particularly anti-tumor necrosis factor alpha (anti-TNF-α) agents, are crucial for treating NIU.
• Biosimilars offer potential alternatives to reference biologics, but their use in NIU requires careful evaluation.

Purpose of the Study:

• To review and compare the efficacy and safety of biologic biosimilar use in adult and pediatric noninfectious uveitis (NIU).
• To assess the current evidence base for biosimilar agents in NIU treatment across different age groups.

Main Methods:

• A comprehensive literature review was conducted using major databases (PubMed, Embase, CENTRAL, Web of Science) up to December 2025.
• Included studies focused on the use of biosimilar biologic agents for adult and/or pediatric NIU.
• Analysis encompassed studies comparing reference biologics with biosimilars and switch studies.

Main Results:

• Most studies focused on adalimumab and infliximab biosimilars for NIU in adults and children.
• Evidence suggests comparable efficacy and safety between biosimilars and reference biologics for NIU.
• Pediatric data on biosimilar use for NIU is significantly underrepresented compared to adult data.

Conclusions:

• Adalimumab and infliximab biosimilars demonstrate effectiveness and safety for NIU treatment in both adult and pediatric populations.
• Further research, including prospective trials in pediatric cohorts and evaluation of other biosimilar agents, is essential.
• Addressing evidence gaps will improve clinical decision-making for biosimilar use in NIU.