The importance of rheumatology biologic registries in Latin America

Vega, Marı́a de la; Carvalho, H.; Ríos, Lucio Ventura; Robles, María Victoria Goycochea; Casado, Gustavo

doi:10.1007/s00296-012-2610-2

Cited by 14 publications

(5 citation statements)

References 34 publications

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“…In the USA, the American College of Rheumatology launched the RISE registry in 2014, in which data are extracted from electronic medical records used by rheumatology practices. However, challenges remain in implementing post-approval surveillance in countries that lack registries or that fail to maintain and update their existing registries [25].…”

Section: A Risk Management Plan (Rmp) For Approved Biosimilarsmentioning

confidence: 99%

PANLAR consensus statement on biosimilars

Kowalski

Benavides²,

Roa³

et al. 2019

Clin Rheumatol

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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

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Section: A Risk Management Plan (Rmp) For Approved Biosimilarsmentioning

confidence: 99%

PANLAR consensus statement on biosimilars

Kowalski

Benavides²,

Roa³

et al. 2019

Clin Rheumatol

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“…From 813 abstracts, we selected 309 publications from 36 registers. Sixteen published reviews allowed us to identify 7 other registries with no publication identified in databases (hand search) [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17].…”

Section: Resultsmentioning

confidence: 99%

Safety of biologic DMARDs in RA patients in real life: A systematic literature review and meta-analyses of biologic registers

2017

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“…El primer reporte fue llevado a cabo en 2011, donde se analizaron 966 pacientes (543 casos y 423 controles), que recibieron 1132 ciclos de tratamientos con agentes biológicos en 56 centros de salud entre el 1º de agosto de 2010 y el 1º de abril de 2011 21,22 .…”

Section: Darío Scublinskyunclassified

Sobre los efectos adversos en la vida real

Scublinsky

2016

Rev. Argent. Reumatol.

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En los tiempos en que la terapéutica farmacológica estaba en sus inicios, allá por fines del siglo XIX, se publica en The Lancet uno de los primeros reportes científicos de efectos adversos, que se trataba de las drogas anestésicas utilizadas en dicho momento. Algunos años después, la American Medical Association publica un artículo donde se denuncian los efectos mortales del jarabe de Winslow, “capaz de calmar a cualquier persona o animal”, que era ni más ni menos que una combinación de morfina y alcohol.

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The importance of rheumatology biologic registries in Latin America

Cited by 14 publications

References 34 publications

PANLAR consensus statement on biosimilars

PANLAR consensus statement on biosimilars

Safety of biologic DMARDs in RA patients in real life: A systematic literature review and meta-analyses of biologic registers

Sobre los efectos adversos en la vida real

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