PANLAR consensus statement on biosimilars

Abstract

Introduction Biologics have improved the treatment of rheumatic diseases, resulting in better outcomes. However, their high cost limits access for many patients in both North America and Latin America. Following patent expiration for biologicals, the availability of biosimilars, which typically are less expensive due to lower development costs, provides additional treatment options for patients with rheumatic diseases. The availability of biosimilars in North American and Latin American countries is evolving, with differing regulations and clinical indications. Objective The objective of the study was to present the consensus statement on biosimilars in rheumatology developed by Pan American League of Associations for Rheumatology (PANLAR). Methods Using a modified Delphi process approach, the following topics were addressed: regulation, efficacy and safety, extrapolation of indications, interchangeability, automatic substitution, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. Consensus was achieved when there was agreement among 80% or more of the panel members. Three Delphi rounds were conducted to reach consensus. Questionnaires were sent electronically to panel members and comments about each question were solicited. Results Eight recommendations were formulated regarding regulation, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. Conclusion The recommendations highlighted that, after receiving regulatory approval, pharmacovigilance is a fundamental strategy to ensure safety of all medications. Registries should be employed to monitor use of biosimilars and to identify potential adverse effects. The price of biosimilars should be significantly lower than that of reference products to enhance patient access. Biomimics are not biosimilars and, if they are to be marketed, they must first be evaluated and approved according to established regulatory pathways for novel biopharmaceuticals. Key Points • Biologics have improved the treatment of rheumatic diseases. • Their high cost limits access for many patients in both North America and Latin America. • Biosimilars typically are less expensive, providing additional treatment options for patients with rheumatic diseases. • PANLAR presents its consensus on biosimilars in rheumatology

Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview

“…The American College of Rheumatology (ACR), since 2014, has implemented the Rheumatology Informatics System for Effectiveness (RISE). This is a database that extracts electronic medical records related to rheumatology [ 17 ]. On the other hand, Latin America and the Caribbean community (CARICOM), made up of 20 developing countries, can use the VigiCarib regional system created in December 2017 to report ADR and changes in the quality of pharmaceutical products [ 18 ].…”

“…In Colombia, the National Food and Drug Surveillance Institute-INVIMA authorised this biopharmaceutical to enter the market through the approval route normally used for generic small molecule drugs [ 37 , 39 ]. In 2019, a retrospective study was carried out evaluating the effectiveness and safety of multiple biotherapeutics in RA, among which were Etanar and innovative etanercept with 92 and 81 patients, respectively [ 17 ]. The opinion of experts on the subject is pending, to determine if this is sufficient to consider Etanar a biosimilar.…”

Biosimilars and the Patent Law

“…This has resulted in the introduction to the market of follow-on products, which we call biosimilars. Biosimilars need to be distinguished now in the legal debate, due to their legal, social, ethical and commercial importance (Rathore, Vulto, Stevenson & Shah, 2019: 22 (Nagel, 2018: 89;Geigert, 2019: 45-47) and another drug category called biomimics or intended copies 4 (Kowalski et al 2019(Kowalski et al : 1486Moots, 2019Moots, : 1498.…”

Biosimilars in the Americas: the future by consensus

“…Within this background, the PANLAR consensus statement on biosimilars has been devised and published [7]. This important development is to be applauded.…”