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Biosimilars in psoriasis: Clinical practice and regulatory perspectives in Latin America
Indexado
WoS WOS:000392419500001
Scopus SCOPUS_ID:84995758201
DOI 10.1111/1346-8138.13512
Año 2017
Tipo revisión

Citas Totales

Autores Afiliación Chile

Instituciones Chile

% Participación
Internacional

Autores
Afiliación Extranjera

Instituciones
Extranjeras


Abstract



Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis in Latin America, the International Psoriasis Council convened dermatology experts from Argentina, Brazil, Chile, Colombia and Mexico in October 2015 to review the definition, approval, marketing and future of biosimilars in each country and develop a consensus statement. The regulatory framework for marketing approval of biosimilars in Latin America is currently a mosaic of disparate, country-specific, regulatory review processes, rules and standards, with considerable heterogeneity in clarity and specificity. Regulations in Argentina, Brazil, Chile and Mexico have undergone multiple refinements whereas Colombia is finalizing draft guidelines. Verification of the similarity in quality, safety and efficacy of biosimilars to the innovator biologic remains a key challenge for policy makers and regulatory authorities. Other key regulatory challenges include: naming of agents and traceability, pharmacovigilance, extrapolation of indications, and interchangeability and substitution. An urgent need exists for more Latin American countries to establish national psoriasis registries and to integrate their common components into a multinational psoriasis network, thereby enhancing their interpretative power and impact. A Latin American psoriasis network similar to PSONET in Europe would assist health-care providers, pharmaceutical companies, regulators and patients to fully comprehend specific products being prescribed and dispensed and to identify potential regional trends or differences in safety or outcomes.

Revista



Revista ISSN
Journal Of Dermatology 0385-2407

Métricas Externas



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Disciplinas de Investigación



WOS
Dermatology
Scopus
Sin Disciplinas
SciELO
Sin Disciplinas

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Publicaciones WoS (Ediciones: ISSHP, ISTP, AHCI, SSCI, SCI), Scopus, SciELO Chile.

Colaboración Institucional



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Autores - Afiliación



Ord. Autor Género Institución - País
1 DE LA CRUZ-FERNANDEZ, CLAUDIA Mujer Clin Dermacross - Chile
Clínica Dermacross - Chile
2 de Carvalho, Andre V. E. Hombre Santa Casa Misericordia Porto Alegre - Brasil
Dermatology Ambulatory - Brasil
3 Dorantes, Gladys L. Mujer Mexican Assoc Psoriasis - México
Mexican Association Against Psoriasis - México
4 LONDONO-GARCIA, ANGELA MARIA Mujer CES Univ - Colombia
5 Gonzalez, Cesar Hombre Clin Univ Colombia - Colombia
Clínica Universitaria Colombia - Colombia
6 Maskin, Matias Hombre CEMIC - Argentina
Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno - Argentina
7 Podoswa, Nancy Mujer HGR1 IMSS - México
Instituto Mexicano del Seguro Social - México
8 Redfern, Jan S. Hombre Redfern Strateg Med Commun - Estados Unidos
Redfern Strategic Medical Communications - Estados Unidos
9 VALENZUELA-ARTEAGA, FERNANDO ANDRES Hombre Universidad de Chile - Chile
Prob Med Res - Chile
10 van der Walt, J. M. Mujer Int Psoriasis Council - Estados Unidos
International Psoriasis Council - Estados Unidos
11 Romiti, R. Hombre UNIV SAO PAULO - Brasil
Universidade de Sao Paulo - USP - Brasil
Universidade de São Paulo - Brasil

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Origen de Citas Identificadas



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Citas identificadas: Las citas provienen de documentos incluidos en la base de datos de DATACIENCIA

Citas Identificadas: 15.38 %
Citas No-identificadas: 84.62 %

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Citas identificadas: Las citas provienen de documentos incluidos en la base de datos de DATACIENCIA

Citas Identificadas: 15.38 %
Citas No-identificadas: 84.62 %

Financiamiento



Fuente
AbbVie
Pfizer
Eli Lilly
Janssen
Galderma

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Agradecimientos



Agradecimiento
Dr de la Cruz is on the speaker bureau of AbbVie and Novartis; received grant/research support from AbbVie, Eli Lilly and Pfizer; and is consultant for AbbVie, Janssen, Novartis and Pfizer. Dr Carvalho received grant/research support from Galderma and Janssen; and is consultant for AbbVie, Glenmark, Janssen, LEO-Pharma and Pfizer. Dr Leon-Dorantes is consultant for Abbvie, Pfizer, Novartis, Lilly, Janssen, Serono, LeoPharma, ISDIN and Galderma. Dr Londono Garcia is consultant for AbbVie, Janssen, Elli Lilly, Novartis and Pfizer. Dr Gonzalez is consultant for AbbVie, Janssen, Elli Lilly, Novartis and Pfizer. Dr Maskin is on the speaker bureau of Abbvie and Novartis, and advisory board member for Lilly. Dr Podoswa declares no conflict of interest. Dr Redfern is consultant for Merck. Dr Valenzuela is on the speaker bureau of Abbvie, Pfizer, Novartis and Jannsen; and is consultant for Abbvie, Pfizer, Novartis and Eli Lilly. Dr Van Der Walt: declares no conflict of interest. Dr Romiti is consultant for AbbVie, Janssen-Cilag, Lilly, Leo-Pharma, Novartis and Pfizer.

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