Anvisa Approves the First Biosimilar Monoclonal Antibody Based on Comparability in Brazil

Teixeira, Fábio Vieira; Kotze, Paulo Gustavo; Damião, Adérson Omar Mourão Cintra

doi:10.1590/s0004-28032016000200002

Cited by 4 publications

(5 citation statements)

References 18 publications

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“…Given that biosimilars for IBD were just recently introduced in Brazil (2015), 7 it was unexpected that 63.4% of Brazilians had been told about biosimilars as compared with 44.0% of the overall IBD population. 10 This information could reflect different educational strategies regarding biosimilars in each country.…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…In Brazil, biosimilars approved for IBD are CT-P13 (REMSIMA®), from the infliximab reference (REMICADE®, Janssen), and the adalimumab biosimilar (AMGEVITA® and HIRIMOZ®), from the adalimumab reference (HUMIRA®, Abbvie). 6,7 Patients may have different perceptions toward these recently introduced drugs, which can create barriers to their uptake. 8 Moreover, improved patient understanding on the rationale for initiating or switching to biosimilars may encourage greater acceptance of biosimilars.…”

Section: Introductionmentioning

confidence: 99%

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Biosimilar knowledge and viewpoints among Brazilian inflammatory bowel disease patients

Garcia

Facas

Machado

et al. 2021

Therap Adv Gastroenterol

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Background: In this analysis we aimed to describe Brazilian inflammatory bowel disease (IBD) patients’ knowledge and perceptions regarding biosimilars and compare with viewpoints from non-Brazilian patients. Methods: An online survey consisting of 19 questions was made available by the European Federation of Crohn’s and Ulcerative Colitis Associations between July 2018 and December 2018. Only respondents who had heard of biosimilars were asked to respond to all of the questions. Results: A total of 102 Brazilian IBD patients responded to the survey. The majority (78.4%) of patients had been exposed to anti-tumor-necrosis-factor drugs and 63.4% of them had heard of biosimilars. Brazilian respondents worried significantly more about biosimilars being less effective than the originator (62.5% versus 47.9%, p value 0.03) and molecular differences between biosimilars and originators (53.1% versus 31.8, p value 0.001) as compared with non-Brazilian IBD patients. The majority of Brazilian (75%) and non-Brazilian (64.1%) respondents thought that the lower cost of biosimilars should not come before their safety and efficacy ( p value 0.09). In addition, 79.1% of Brazilian respondents believed that the arrival of biosimilars will have an impact on the management of IBD. Conclusions: Brazilian patients reported higher rates of misconceptions regarding biosimilars than non-Brazilian IBD patients. Although patients still worry about different aspects regarding biosimilars, they also tend to be confident that biosimilars will have an impact on the management of their disease. With the recent approval of many biosimilars in Brazil and the imminent widespread use of these drugs, our data raise awareness for the need of providing patient education to prevent negative expectations toward switching to biosimilars.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Biosimilar knowledge and viewpoints among Brazilian inflammatory bowel disease patients

Garcia

Facas

Machado

et al. 2021

Therap Adv Gastroenterol

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“…77,78 Authorization of CT-P13 in Brazil represented the first approval of a mAb biosimilar via ANVISA’s comparative pathway. 79 Since that time, ANVISA has approved an etanercept biosimilar (SB4; Brenzys™) and a trastuzumab biosimilar (MYL-1401O; Zedora). 80,81 As described in later sections, these products were previously authorized as biosimilars in highly regulated markets including the EU (SB4) and US (MYL-1401O), having each demonstrated biosimilarity to the respective originator product through an extensive comparison exercise.…”

Section: Biosimilars In Latin America: Current Situationmentioning

confidence: 99%

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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“…Actualmente hay un fuerte interés en la introducción de AcMo biosimilares en diferentes mercados de Latinoamérica; en abril del 2015 Brasil aprobó el uso del primer AcMo biosimilar (57). Se espera que esta clase de productos, debido a su menor precio, permita una mayor penetración de los AcMo recombinantes en el mercado.…”

Section: Biosimilaresunclassified

Present and future of therapeutic recombinant antibodies

Langjahr

Sotelo

2016

Mem. Inst. Investig. Cienc. Salud

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Cómo referenciar este artículo/ How to reference this article: Langjahr P I,II , Sotelo P III . Presente y futuro de los anticuerpos recombinantes terapéuticos. Mem. Inst. Investig. Cienc. Salud. 2016;14(2):110-21 R E S U M E NLos anticuerpos constituyen un componente fundamental del sistema inmune, permitiendo el reconocimiento con alta especificidad y posterior destrucción de moléculas extrañas. Los anticuerpos monoclonales, producidos por la tecnología del hibridoma, presentan desventajas para su uso en terapia humana debido a su origen en una especie diferente. La ingeniería genética posibilitó la utilización de los anticuerpos monoclonales para terapias humanas, generando los anticuerpos recombinantes terapéuticos. Así, los anticuerpos recombinantes se han transformado en un importante grupo de fármacos; con decenas de ellos aprobados para terapia humana y cientos en desarrollo. Se utilizan con éxito como tratamiento para un amplio rango de patologías, tales como cáncer, autoinmunidad e infecciones, siendo desde hace años el biofármaco con mayores ventas. Inicialmente todos los anticuerpos recombinantes terapéuticos presentaban la estructura convencional de los anticuerpos. Sin embargo, más recientemente, se han generado nuevos diseños que no poseen las características estructurales naturales, como los anticuerpos de simple cadena y bi-específicos. Debido al desarrollo y éxito de la tecnología de anticuerpos recombinantes, se espera un aumento constante en el número de anticuerpos terapéuticos contra nuevos blancos, además de la generación de nuevas estructuras, usos y estrategias terapéuticas. En esta revisión, nos centraremos en las características estructurales y los nuevos formatos de anticuerpos, así como su aplicación clínica en el tratamiento de diversas patologías. Además analizaremos los nuevos formatos de anticuerpos que se encuentran en el mercado y la aparición de los anticuerpos biosimilares. Palabras clave: inmunoglobulinas, anticuerpos monoclonales, proteínas recombinantes, anticuerpos terapéuticos Present and future of therapeutic recombinant antibodies A B S T R A C TAntibodies are a key component of the immune system, acting in the highly specific recognition and subsequent destruction of foreign molecules. Monoclonal antibodies produced by hybridoma technology have disadvantages for use in human therapy because of its origin in a different species. Genetic engineering enabled the use of monoclonal antibodies for human therapies, generating recombinant therapeutic antibodies.Thus, the recombinant antibodies have become an important group of drugs; dozens of them are approved for human therapy and there are hundreds in development. They are successfully used as a treatment for a wide range of pathologies, such as cancer, autoimmunity and infections, being the biopharmaceutical with higher sales. Initially therapeutic recombinant antibodies showed the conventional structure of the antibodies.

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Anvisa Approves the First Biosimilar Monoclonal Antibody Based on Comparability in Brazil

Abstract: Teixeira FV, Kotze PG, Damião AOMC. ANVISA approves the first biosimilar monoclonal antibody based on comparability in Brazil. HEADINGS -Biosimilar pharmaceuticals. Crohn disease. Ulcerative colitis.This article did not have any founding source Study

Cited by 4 publications

References 18 publications

Biosimilar knowledge and viewpoints among Brazilian inflammatory bowel disease patients

Biosimilar knowledge and viewpoints among Brazilian inflammatory bowel disease patients

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

Present and future of therapeutic recombinant antibodies

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