PANLAR consensus statement on biosimilars

Area of Science:

• Rheumatology
• Pharmacoeconomics
• Regulatory Science

Background:

• Biologic therapies have significantly advanced rheumatic disease treatment.
• High costs of biologics limit patient access in North America and Latin America.
• Biosimilars, emerging after patent expiration, offer cost-effective alternatives.

Purpose of the Study:

• To present the consensus statement on biosimilars in rheumatology from the Pan American League of Associations for Rheumatology (PANLAR).

Main Methods:

• A modified Delphi process involving multiple rounds of electronic questionnaires.
• Consensus defined as agreement among 80% or more of panel members.
• Key topics included regulation, safety, efficacy, economics, and pharmacovigilance.

Main Results:

• Eight key recommendations were formulated across regulation, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics.
• Emphasis on post-approval pharmacovigilance and the use of registries for monitoring.
• Recommendations address the need for significantly lower biosimilar pricing to enhance access.

Conclusions:

• Pharmacovigilance is crucial for ensuring the safety of all medications post-regulatory approval.
• Registries are essential for monitoring biosimilar use and identifying adverse effects.
• Biomimics require separate regulatory evaluation and approval; they are not biosimilars.