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PANLAR consensus statement on biosimilars.

S C Kowalski1, J A Benavides2, P A B Roa2

  • 1Universidade Federal do Paraná, R. Gen. Carneiro, 181 - Alto da Glória, Curitiba, PR, 80060-900, Brazil. sckowalskii@gmail.com.

Clinical Rheumatology
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PubMed
Summary
This summary is machine-generated.

Biosimilars offer more affordable treatment options for rheumatic diseases, improving patient access. The Pan American League of Associations for Rheumatology (PANLAR) developed consensus recommendations for their safe and effective use.

Keywords:
BiosimilarsConsensusPANLARRheumatic diseases

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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.