PANLAR consensus statement on biosimilars

被引：14

作者：

Kowalski, S. C. ^{[1
]}

Benavides, J. A. ^{[2
]}

Roa, P. A. B. ^{[2
]}

Galarza-Maldonado, C. ^{[3
,4
]}

Caballero-Uribe, C., V ^{[3
,5
]}

Soriano, E. R. ^{[3
]}

Pineda, C. ^{[3
]}

Azevedo, V. F. ^{[3
]}

Avila-Pedretti, G. ^{[6
]}

Babini, A. M. ^{[7
]}

Cachafeiro-Vilar, A. ^{[8
]}

Cifuentes-Alvarado, M. ^{[9
]}

Cohen, S. B. ^{[10
]}

Diaz, P. E. ^{[11
]}

Diaz Soto, L. ^{[12
]}

Encalada, C. ^{[13
]}

Garro, B. ^{[14
]}

Sariego, I. A. G. ^{[15
]}

Guibert-Toledano, M. ^{[16
]}

Rodriguez, V. J. K. ^{[17
]}

Lopez, M. E. L. ^{[17
]}

Ortega, A. P. ^{[18
]}

Russell, A. S. ^{[19
]}

Santos-Moreno, P. ^{[20
]}

Teran, I. S. ^{[21
]}

Vargas, A. ^{[22
]}

Vasquez, G. ^{[20
]}

Xavier, R. M. ^{[23
]}

Xibille Firedman, D. X. ^{[24
]}

Mysler, E. ^{[7
]}

Kay, J. ^{[10
]}

机构：

[1] Univ Fed Parana, R Gen Carneiro 181, BR-80060900 Curitiba, Parana, Brazil

[2] Cencis, Av Cra 45 114-78 Edificio Espectrum,Oficina 101, Bogota, Colombia

[3] PANLAR Pan Amer League Assoc Rheumatol, 2200 Lake Blvd NE, Atlanta, GA 30319 USA

[4] Corp Med Monte Sinai, UNERA Unidad Enfermedades Reumat & Autoinmunes, Cuenca 010107, Ecuador

[5] Hosp Univ Norte, Unidad Reumatol, Calle 30 Via A1 Aeropuerto, Soledad Atlantico, Colombia

[6] Soc Paraguaya Reumatol, Pitiantuta 613 Esq Juan de Salazar, Asuncion, Paraguay

[7] Soc Argentina Reumatol, Callao 384 Piso 2 Dto 6,C1022AAQ, Buenos Aires, DF, Argentina

[8] Soc Panamena Reumatol, Blvd Pacifica & Via Puunta Darien, Panama City, Panama

[9] Asociac Guatemalteca Reumatol, 10a Calle 6-40 Zona 9 Clin 1 2Do Nivel Edificio, Guatemala City, Guatemala

[10] Amer Coll Rheumatol, 2200 Lake Blvd NE, Atlanta, GA USA

[11] Inst Boliviano Reumatol, Soc Boliviana Reumatol, Av Irala, Santa Cruz, Bolivia

[12] Hosp Mexico, Asociac Costanicense Reumatol, Reumatol, Caja Costarricense Seguro Social, San Jose, Costa Rica

[13] Soc Ecuatoriana Reumatol, Edificio Torre Med 4,Piso 1,Coronel 2207 & Canar, Guayaquil, Ecuador

[14] Soc Peruana Reumatol, Av Jose Pardo 138 Oficina 1206 Miraflores, Lima, Peru

[15] Soc Chilena Reumatol, Av Nueva Providencia, Providencia 2214, Region Metropol, Chile

[16] Soc Cuban Reumatol, Calzada 10 Octubre 122, Havana, Cuba

[17] Soc Dominicana Reumatol, Primer Nivel Local 47 A Diamond Mall, Santo Domingo, Dominican Rep

[18] Asociac Reumatol Nicaraguense, Bello Horizonte Rotonda 4 1-2 Cuadras Sur J 2 9, Managua, Nicaragua

[19] Canadian Rheumatol Assoc, 9-6975 Meadowvale Town Ctr Circle Suite 108, Toronto, ON L5N 2V7, Canada

[20] Asociac Colombiana Reumatol, Calle 94 15-32 Oficina 603, Bogota, Colombia

[21] Soc Venezolana Reumatol, Apartado 5495, Caracas 1010, Venezuela

[22] Soc Uruguaya Reumatol, Av Italia S-N Esq Las Heras 1er Piso Sect, Montevideo, Uruguay

[23] Soc Brasileira Reumatol, Av Brigadeiro Luis Antonio 2466, BR-01402000 Sao Paulo, SP, Brazil

[24] Colegio Mexicano Reumatol, Paseo Rio 157, Mexico City 04318, DF, Mexico

来源：

CLINICAL RHEUMATOLOGY | 2019年 / 38卷 / 05期

关键词：

Biosimilars; Consensus; PANLAR; Rheumatic diseases; RHEUMATOID-ARTHRITIS; REGULATORY PERSPECTIVES; INFLIXIMAB CT-P13; LATIN-AMERICA; RECOMMENDATIONS; CHALLENGES; GUIDELINES; THERAPIES; DISEASE; SAFETY;

D O I：

10.1007/s10067-019-04496-3

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

IntroductionBiologics 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.ObjectiveThe objective of the study was to present the consensus statement on biosimilars in rheumatology developed by Pan American League of Associations for Rheumatology (PANLAR).MethodsUsing 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.ResultsEight recommendations were formulated regarding regulation, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics.ConclusionThe 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 center dot Biologics have improved the treatment of rheumatic diseases.center dot Their high cost limits access for many patients in both North America and Latin America.center dot Biosimilars typically are less expensive, providing additional treatment options for patients with rheumatic diseases.center dot PANLAR presents its consensus on biosimilars in rheumatology

引用

页码：1485 / 1496

页数：12

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