O brasil e o panorama regulatório de medicamentos biossimilares - comparação com europa, estados unidos, austrália e canadá
Data
2022-12-19
Autores
Porcino, Gustavo da Silva 
Orientadores
Melo, Daniela Oliveira de
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Introdução: A autorização e uso de medicamentos biossimilares é um tema de alta relevância nos últimos anos, desde a aprovação do primeiro biossimilar em 2006 na Europa. Desde então, as agências sanitárias mundiais vêm construindo diretrizes que estabelecem as necessidades para o registro destes, considerando seu contexto mercadológico e a necessidade da redução de custos em saúde. O presente estudo comparou o panorama das agências sanitárias da Europa, Austrália, Canadá, Estados Unidos e Brasil, com o objetivo de avaliar qualitativa e quantitativamente como a agência brasileira se posiciona quanto à aprovação destes produtos, levando em consideração os marcos regulatórios e a ampliação das parcerias para o desenvolvimento produtivo (PDPs). Materiais e métodos: Foi realizada uma busca, através das bases de dados específicas para cada órgão regulador de cada país/região elencada, sobre informações de registro de medicamentos biossimilares até 23 de abril de 2022. Posteriormente, foram adicionadas informações específicas sobre os medicamentos biossimilares registrados na Agência Nacional de Vigilância Sanitária (ANVISA), como a data de registro, o tempo de análise e a origem do registro. Resultados: Foram identificados 117 registros válidos de medicamentos biossimilares nas cinco agências regulatórias avaliadas, sendo 68 especificamente na agência europeia. Do número total, 29 produtos biossimilares foram registrados somente na ANVISA, enquanto 22 possuíam aprovação apenas na European Medicines Agency (EMA). Do total de produtos com registros de biossimilares, o princípio ativo Adalimumabe aparece com o maior número (35, totalizando 29% das autorizações). Quanto à ANVISA, dos 59 biossimilares registrados, 9 foram autorizados antes da Resolução da Diretoria Colegiada (RDC) nº 55/2010, que determina e estabelece os critérios para medicamentos biossimilares. Considerando registros relacionados à uma PDP, existem 7 produtos atualmente aprovados, e o tempo de análise médio destes se mostra 83% menor do que em petições comuns. Discussão e conclusão: Foi possível identificar que as agências avaliadas possuem algumas similaridades quanto à regulamentação para o registro de biossimilares, tanto no que tange suas diretrizes como no padrão de produtos autorizados até 23 de abril de 2022. Apesar disso, a agência sanitária brasileira demonstra importantes diferenças, principalmente no que diz respeito à produtos aprovados antes e depois da RDC nº 55/2010. Também, foi possível notar que a ampliação das PDPs foi importante fator para a ampliação do número de biossimilares registrados no país.
Introduction: The authorization and use of biosimilar medicines has been a topic of high relevance in recent years, since the approval of the first biosimilar in 2006 in Europe. Since then, global health agencies have been building guidelines that establish the needs for registering these products, considering their market context and the need to reduce health related costs. The present study compared the landscape of health agencies in Europe, Australia, Canada, the United States and Brazil, with the objective of qualitatively and quantitatively evaluate how the Brazilian agency positions itself regarding the approval of biosimilars, taking into consideration the regulatory framework and the expansion of partnerships for productive development (PDPs). Materials and methods: A search was performed through the specific databases for each regulatory agency listed, to gather regulatory information of biosimilar medicines until April 23, 2022. Later, specific information on approved biosimilar medicines on Agência Nacional de Vigilância Sanitária (ANVISA) were added, such as the date of registration, the time of analysis and the origin of the registration. Results: 117 valid registrations of biosimilar medicines were identified in the five regulatory agencies evaluated, 68 specifically in the European agency. Of the total number, 29 biosimilar products were only registered with ANVISA, while 22 were approved only in the European Medicines Agency (EMA). Of the total number of products with biosimilar registrations, the active ingredient Adalimumab appears with the highest number (35, totaling 29% of authorizations). As for ANVISA, of the 59 biosimilars registered, 9 were authorized before Resolução da Diretoria Colegiada (RDC) nº 55/2010, which determines and establishes the criteria for biosimilar medicines. Considering records related to a PDP, there are 7 products currently approved, and their average analysis time is 83% lower than in common petitions. Discussion and conclusion: It was possible to verify that the evaluated agencies have some similarities regarding the regulation for the registration of biosimilars, both in terms of their guidelines and in the standard of products authorized until April 23, 2022. Despite this, the Brazilian health agency demonstrates important differences, especially with regard to products approved before and after RDC nº 55/2010. It was also possible to note that the expansion of PDPs was an important factor for the increase in the number of biosimilars registered in the country.
Introduction: The authorization and use of biosimilar medicines has been a topic of high relevance in recent years, since the approval of the first biosimilar in 2006 in Europe. Since then, global health agencies have been building guidelines that establish the needs for registering these products, considering their market context and the need to reduce health related costs. The present study compared the landscape of health agencies in Europe, Australia, Canada, the United States and Brazil, with the objective of qualitatively and quantitatively evaluate how the Brazilian agency positions itself regarding the approval of biosimilars, taking into consideration the regulatory framework and the expansion of partnerships for productive development (PDPs). Materials and methods: A search was performed through the specific databases for each regulatory agency listed, to gather regulatory information of biosimilar medicines until April 23, 2022. Later, specific information on approved biosimilar medicines on Agência Nacional de Vigilância Sanitária (ANVISA) were added, such as the date of registration, the time of analysis and the origin of the registration. Results: 117 valid registrations of biosimilar medicines were identified in the five regulatory agencies evaluated, 68 specifically in the European agency. Of the total number, 29 biosimilar products were only registered with ANVISA, while 22 were approved only in the European Medicines Agency (EMA). Of the total number of products with biosimilar registrations, the active ingredient Adalimumab appears with the highest number (35, totaling 29% of authorizations). As for ANVISA, of the 59 biosimilars registered, 9 were authorized before Resolução da Diretoria Colegiada (RDC) nº 55/2010, which determines and establishes the criteria for biosimilar medicines. Considering records related to a PDP, there are 7 products currently approved, and their average analysis time is 83% lower than in common petitions. Discussion and conclusion: It was possible to verify that the evaluated agencies have some similarities regarding the regulation for the registration of biosimilars, both in terms of their guidelines and in the standard of products authorized until April 23, 2022. Despite this, the Brazilian health agency demonstrates important differences, especially with regard to products approved before and after RDC nº 55/2010. It was also possible to note that the expansion of PDPs was an important factor for the increase in the number of biosimilars registered in the country.