S C Kowalski1, J A Benavides2, P A B Roa2, C Galarza-Maldonado3,4, C V Caballero-Uribe3,5, E R Soriano3, C Pineda3, V F Azevedo3, G Avila-Pedretti6, A M Babini7, A Cachafeiro-Vilar8, M Cifuentes-Alvarado9, S B Cohen10, P E Díaz11, L Diaz Soto12, C Encalada13, B Garro14, I A G Sariego15, M Guibert-Toledano16, V J K Rodriguez17, M E L Lopez17, A P Ortega18, A S Russell19, P Santos-Moreno20, I S Terán21, A Vargas22, G Vásquez20, R M Xavier23, D X Xibillé Firedman24, E Mysler7, J Kay10. 1. Universidade Federal do Paraná, R. Gen. Carneiro, 181 - Alto da Glória, Curitiba, PR, 80060-900, Brazil. sckowalskii@gmail.com. 2. Cencis, Av. Cra 45 # 114-78 Edificio Espectrum, oficina 101, Bogota, Colombia. 3. PANLAR (Pan American League of Associations for Rheumatology), 2200 Lake Boulevard NE, Atlanta, GA, 30319, USA. 4. UNERA-Unidad de Enfermedades Reumaticas y Autoinmunes, Corporacion Medica Monte Sinai, 010107, Cuenca, Ecuador. 5. Hospital Universidad del Norte-Unidad de Reumatologia, Calle 30 Via Al Aeropuerto, Soledad-Atlantico, Colombia. 6. Sociedad Paraguaya de Reumatología, Pitiantuta 613 esq. Juan de Salazar, Asuncion, Paraguay. 7. Sociedad Argentina de Reumatología, Callao 384 Piso 2 Dto 6, CABA, C1022AAQ, Buenos Aires, Argentina. 8. Sociedad Panameña de Reumatología, Boulevard Pacífica y Vía Punta Darién, Panama City, Panamá. 9. Asociación Guatemalteca de reumatología, 10a. Calle 6-40. Zona 9 Clínica 1. 2do Nivel Edificio Salucentro, Guatemala City, Guatemala. 10. American College of Rheumatology, 2200 Lake Boulevard NE, Atlanta, GA, 303192200, USA. 11. Sociedad Boliviana de Reumatología, Instituto Boliviano de Reumatología, Av. Irala, Santa Cruz de la Sierra, Bolivia. 12. Asociacion Costarricense de Reumatologia, Reumatología, Hospital México, Caja Costarricense del Seguro Social, San Jose, Costa Rica. 13. Sociedad Ecuatoriana de Reumatología, Edificio Torre Médica #4 Piso 1, Coronel 2207 y cañar (994,96 km), Guayaquil, Ecuador. 14. Sociedad Peruana de Reumatología, Av. José Pardo 138 oficina 1206 Miraflores, Lima, Peru. 15. Sociedad Chilena de reumatología, Av. Nueva Providencia, 2214, Providencia, Región Metropolitana, Chile. 16. Sociedad Cubana de Reumatología, Calzada de 10 de Octubre # 122, esquina Agua dulce Cerro, Havana, Cuba. 17. Sociedad Dominicana de Reumatología, Primer Nivel Local 47 A. Diamond Mall, Santo Domingo, Dominican Republic. 18. Asociación de Reumatología Nicaragüense, Bello Horizonte rotonda 4 ½ cuadras al sur. J II 9, Managua, Nicaragua. 19. Canadian Rheumatology Association, 9-6975 Meadowvale Town Centre Circle Suite 108 Mississauga, Toronto, Ontario, L5N 2V7, Canada. 20. Asociación Colombiana de Reumatología, Calle 94 # 15-32 Oficina 603, Bogota, Colombia. 21. Sociedad Venezolana de Reumatología, Apartado 5495, Caracas, 1010, Venezuela. 22. Sociedad Uruguaya de Reumatología, Av.Italia s/n esq. Las Heras 1er. Piso Sector, Montevideo, Uruguay. 23. Sociedade Brasileira de Reumatología, Av. Brigadeiro Luís Antônio, 2466 - Jardim Paulista, Sao Paulo, SP, 01402-000, Brazil. 24. Colegio Mexicano de Reumatología, Paseo del Río No. 157 Col. Barrio Oxtopulco Universidad, Delegación Coyoacán, Cd., CP 04318, Mexico City, Mexico.
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.
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.
Authors: Mustafa Al Maini; Femi Adelowo; Jamal Al Saleh; Yousef Al Weshahi; Gerd-Rüdiger Burmester; Maurizio Cutolo; Joseph Flood; Lyn March; Heather McDonald-Blumer; Kevin Pile; Carlos Pineda; Carter Thorne; Tore K Kvien Journal: Clin Rheumatol Date: 2014-12-14 Impact factor: 2.980
Authors: Evelien Moorkens; Clara Jonker-Exler; Isabelle Huys; Paul Declerck; Steven Simoens; Arnold G Vulto Journal: Front Pharmacol Date: 2016-06-29 Impact factor: 5.810
Authors: Antoine Perpoil; Gael Grimandi; Stéphane Birklé; Jean-François Simonet; Anne Chiffoleau; François Bocquet Journal: Int J Environ Res Public Health Date: 2020-12-29 Impact factor: 3.390