Recommendations on the use of biosimilars by the Brazilian Society of Rheumatology, Brazilian Society of Dermatology, Brazilian Federation of Gastroenterology and Brazilian Study Group on Inflammatory Bowel Disease—Focus on clinical evaluation of monoclonal antibodies and fusion proteins used in the treatment of autoimmune diseases

Azevedo, Valderílio Feijó; Meirelles, Eduardo de Souza; Kochen, Jussara de Almeida Lima; Medeiros, Ana Cristina; Miszputen, Sender Jankiel; Teixeira, Fábio Vieira; Damiao, Aderson O.; Kotze, Paulo Gustavo; Romiti, Ricardo; Arnone, Marcelo; Magalhães, Renata Ferreira; Maia, Cláudia Pires Amaral; Carvalho, André Vicente Esteves de

doi:10.1016/j.autrev.2015.04.014

Cited by 26 publications

(26 citation statements)

References 34 publications

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“…The introduction of biosimilars has been supported by learned societies in Latin America 144–146 ; however, on the basis of the discussion above, we believe that several key aspects of biosimilars should be considered by healthcare professionals in these countries.…”

Section: Implications and Considerations For Clinicians In Latin Americamentioning

confidence: 99%

“…Experts from Latin America have indicated their support for the extrapolation of indications if it is soundly and scientifically justified, 84,144 for example by demonstrating that the active substance has the same mode of action and target receptors from indication to indication. Indeed, a 2018 position statement on biosimilars from the Brazilian Society of Clinical Oncology emphasizes that decisions regarding extrapolation “should be made on a case-by-case basis,” rather than automatically.…”

Section: Implications and Considerations For Clinicians In Latin Americamentioning

confidence: 99%

“…30 Because pharmacovigilance efforts are suboptimal in many Latin American countries, healthcare professionals in the region have a key part to play in post-marketing surveillance by reporting AEs and attributing them accurately. 45,84,144 In a survey of prescribers in Argentina, Brazil, Colombia, and Mexico, approximately half of respondents claimed that they either reported AEs for biologics rarely (25%) or reported only some AEs (28%); 9% stated that they never reported AEs. 28 As such, a cultural shift may be required in the medical community towards giving greater importance to reporting AEs.…”

Section: Implications and Considerations For Clinicians In Latin Americamentioning

confidence: 99%

“…144 This is particularly important in countries such as Argentina, Colombia, Mexico, and Brazil, where the use of brand names is not permitted when prescribing within the public health system; distinct non-proprietary names for biosimilars would be needed to solve this problem. 84 Indeed, Brazilian medical societies have expressed their support for a distinctive nomenclature system for biosimilars and originator products.…”

Section: Implications and Considerations For Clinicians In Latin Americamentioning

confidence: 99%

“…84 Indeed, Brazilian medical societies have expressed their support for a distinctive nomenclature system for biosimilars and originator products. 144,145 One suggestion has been to use the manufacturer’s name as a unique identifier. 84 As biosimilar guidelines in Latin America do not consider the naming of these agents, 46 this remains an area for clarification.…”

Section: Implications and Considerations For Clinicians In Latin Americamentioning

confidence: 99%

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Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Scheinberg

Pineda

Castañeda‐Hernández

et al. 2018

mAbs

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Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product. Biosimilars have the potential to provide savings to healthcare systems and expand patient access to biologics. In Latin American countries, regulatory frameworks for biosimilar approval have been introduced in recent years, and biosimilars of monoclonal antibody and fusion protein therapies are now emerging. However, the situation in this region is complicated by the presence of “non-comparable biotherapeutics” (also known as “intended copies”), which have not been rigorously compared with the originator product. We review the considerations for clinicians in Latin American countries, focusing on monoclonal antibody biosimilars relevant to oncology, rheumatology, gastroenterology, and dermatology.

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Section: Implications and Considerations For Clinicians In Latin Americamentioning

confidence: 99%

Section: Implications and Considerations For Clinicians In Latin Americamentioning

confidence: 99%

Section: Implications and Considerations For Clinicians In Latin Americamentioning

confidence: 99%

Section: Implications and Considerations For Clinicians In Latin Americamentioning

confidence: 99%

Section: Implications and Considerations For Clinicians In Latin Americamentioning

confidence: 99%

See 3 more Smart Citations

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Scheinberg

Pineda

Castañeda‐Hernández

et al. 2018

mAbs

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Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

Castañeda‐Hernández

Sandoval

Coindreau

et al. 2019

Pharmacoepidemiology and Drug

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Purpose This review summarises the current status of regulatory guidelines for the approval of biosimilars in Latin America and highlights the main barriers to effective pharmacovigilance in this region. We also report results from a survey of Latin American rheumatologists assessing their understanding of prescribing biosimilars and the pharmacovigilance of these drugs. Methods We reviewed the current guidelines for the regulatory approval of biosimilars and barriers to effective pharmacovigilance in Latin American countries. Rheumatologists attending the II Pan‐American League of Rheumatology Associations PANLAR Review Course (Biosimilars update) in Lima, Peru were asked to complete a short survey to determine their knowledge of biosimilars. Results Many Latin American countries continue to lag behind Europe and the United States in establishing regulatory guidance and effective pharmacovigilance systems for biosimilars. Results from our survey also highlight a lack of awareness regarding the availability of biosimilars, their nomenclature, automatic substitution, and reporting adverse drug reactions because of these drugs. Conclusions The main barriers to effective pharmacovigilance in Latin America are the lack of consensus on the interchangeability of reference biologics and biosimilars, and the need for more suitably trained personnel to carry out effective postmarketing pharmacovigilance of biosimilars. Inconsistencies in biosimilar nomenclature make it difficult to adequately trace drugs and record adverse drug reactions associated with their use, creating a barrier to the global pharmacovigilance of biologics.

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Biosimilars in the Treatment of Inflammatory Bowel Disease

Huang

Fedorak

2017

Crohn's Disease and Ulcerative Colitis

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Cited by 26 publications

References 34 publications

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

Biosimilars in the Treatment of Inflammatory Bowel Disease

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