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Braz. J. Pharm. Sci. (Online) ; 57: e19087, 2021. tab, graf
Article in English | LILACS | ID: biblio-1345459


This study aims to analyze the new drugs registered in Brazil from 2003 to 2013 from the perspective of childcare needs, drug safety and considering the disease burden of the country. This is a retrospective cohort study including new drugs registered in Brazil between 2003 and 2013. Drug indications were related to the Disability-Adjusted Life Year (DALY) of the 2015 Global Burden of Disease Study. Association between the number of new drugs and DALY was determined by Spearman's coefficient. Post-marketing safety alerts specific to the pediatric population have been identified in the WHO Drug Information Bulletin and on websites of drug regulatory agencies. A total of 134 new drugs were included in the cohort and 46 (34.3%) had a pediatric indication. There was no evidence of an association between the disease burden in children in Brazil and the number of pediatric drugs. The safety alert data associated with the pediatric population published after registration of the new drugs were scarce. The number of new drugs launched in Brazil with a pediatric indication was small, reflecting the international challenges of developing effective and safe medicines for children. No association was found between the number of new drugs and the disease burden.

Brazil/ethnology , Pharmaceutical Preparations/analysis , Drug Approval/legislation & jurisprudence , World Health Organization , Child Care/methods , Child Health/classification , Cohort Studies , Reference Drugs , Health Services Needs and Demand/classification
Rev. panam. salud pública ; 45: e10, 2021. tab, graf
Article in English | LILACS | ID: biblio-1252027


ABSTRACT Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries' regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. Methods. Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. Results. Regulatory documents regarding marketing authorization were found in 20 LAC regulators' websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. Conclusions. Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

RESUMEN Objetivo. Describir el estado actual de la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones en América Latina y el Caribe mediante la evaluación de los marcos regulatorios nacionales para la aprobación de nuevos medicamentos y establecer los organismos regulatorios extranjeros que se consideran autoridades regulatorias confiables para cada país. Métodos. Se realizaron búsquedas en los sitios web de las autoridades regulatorias de América Latina y el Caribe para identificar las regulaciones oficiales para la aprobación de nuevos medicamentos. La recopilación de datos se llevó a cabo en diciembre del 2019 y se completó en junio del 2020 para los países del Caribe. Dos equipos independientes recopilaron información sobre el reconocimiento directo o los procedimientos abreviados para la aprobación de nuevos medicamentos y los autoridades regulatorias de referencia (confiables) así definidos en la legislación nacional correspondiente. Resultados. Se encontraron documentos regulatorios sobre la aprobación de nuevos productos en los sitios web de veinte organismos regulatorios de América Latina y el Caribe, que abarcaban 34 países. Siete países no aceptan la utilización de decisiones de autoridades regulatorias extranjeras. Trece autoridades regulatorias (Argentina, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, México, Panamá, Paraguay, Perú, República Dominicana, Uruguay y el sistema regulador único para quince Estados del Caribe) aceptan de manera explícita confiar las decisiones para aprobación de nuevos medicamentos emitidas por la Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá. Diez países aceptan también utilizar las autorizaciones para la comercialización de Australia, Japón y Suiza. Argentina, Brasil, Chile y México son autoridades de referencia para ocho autoridades regulatorias en la región. Conclusiones. La utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se han convertido en una práctica común en América Latina y el Caribe. Trece de veinte autoridades regulatorias reconocen directamente o abrevian el proceso de aprobación de nuevos medicamentos en caso de que hayan recibido previamente la aprobación por parte de un organismo regulatorio de otra jurisdicción. La Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá son las autoridades regulatorias de otras jurisdicciones en las cuales los reguladores de América Latina y el Caribe confían más.

RESUMO Objetivo. Descrever a prática atual de uso de decisões regulatórias de outras jurisdições na América Latina e no Caribe (ALC) mediante avaliação os marcos regulatórios dos países para aprovação de novos medicamentos e verificar, para cada país, quais entidades reguladoras estrangeiras são consideradas autoridades reguladoras de confiança por cada país. Métodos. Foi realizada uma pesquisa nos sites das autoridades reguladoras da ALC para identificar as regulamentações oficiais para aprovação de novos medicamentos. A coleta de dados foi feita em dezembro de 2019 e concluída em junho de 2020 para os países do Caribe. Dois grupos independentes coletaram informações sobre o reconhecimento direto ou o procedimento abreviado para aprovação de novos medicamentos e as autoridades reguladoras de referência (de confiança) definidas como tal pela respectiva legislação nacional. Resultados. Documentos regulatórios relacionados à aprovação de novos produtos foram obtidos de 20 sites de órgãos reguladores da ALC, abrangendo 34 países. Sete países não admitem o uso de decisões regulatórias de entidades reguladoras externas. Treze autoridades reguladoras (na Argentina, Colômbia, Costa Rica, El Salvador, Equador, Guatemala, México, Panamá, Paraguai, Peru, República Dominicana, Uruguai e o Sistema Regulador do Caribe unificado para 15 Estados caribenhos) admitem explicitamente a admissibilidade de decisões regulatórias para aprovação de novos medicamentos de outras jurisdições, quais sejam: Agência Europeia de Medicamentos (EMA), Agência Reguladora de Alimentos e Medicamentos (FDA) dos EUA e Health Canada. Dez países também aceitam decisões para autorização de comercialização da Austrália, Japão e Suíça. Argentina, Brasil, Chile e México são autoridades de referência para oito agências reguladoras. Conclusões. O uso de decisões regulatórias de outras jurisdições tornou-se prática comum na América Latina e Caribe. Treze das 20 agências reguladoras reconhecem diretamente ou abreviam o procedimento de aprovação de novos medicamentos no caso de tal aprovação já haver sido concedida por uma autoridade reguladora de outra jurisdição. A EMA, a FDA e a Health Canada são as autoridades estrangeiras nas quais as agências reguladoras da América Latina e Caribe mais confiam.

Drug Approval/legislation & jurisprudence , Government Regulation , Cross-Sectional Studies , Caribbean Region , Latin America
Einstein (Säo Paulo) ; 16(3): eRW4175, 2018. tab
Article in English | LILACS | ID: biblio-953180


ABSTRACT The manufacturing process for biological products is complex, expensive and critical to the final product, with an impact on their efficacy and safety. They have been increasingly used to treat several diseases, and account for approximately 50% of the yearly budget for the Brazilian public health system. As the patents of biological products expire, several biosimilars are developed. However, there are concerns regarding their efficacy and safety; therefore, the regulatory agencies establish rules to approve and monitor these products. In Brazil, partnership programs between national government-owned companies and private technology holders have been implemented, aiming at knowledge sharing, capacity-building and technological transfer. Such partnerships locally promote manufacturing of these strategic drugs at reduced costs to the public health system. These agreements offer mutual advantages to both the government and patent holders: for the former, a biotechnological development flow is established and enables potential cost reduction and self-sufficient production; whereas for the latter, exclusive sales of the product are ensured during technological transfer, for a fixed period.

RESUMO O processo de manufatura de produtos biológicos é complexo, oneroso e crítico para o produto final, com impacto em sua eficácia e segurança. Seu uso está sendo cada vez mais ampliado no tratamento de diversas doenças, e cerca de 50% do orçamento anual do sistema de saúde público brasileiro é consumido por tais produtos. Com o término da proteção de patentes de produtos biológicos diversos, estão sendo desenvolvidos os biossimilares. Porém, há preocupações relacionadas com sua eficácia e segurança, fazendo com que os órgãos reguladores criem regulamentações para sua aprovação e monitoramento. No Brasil, estão sendo implantados programas de parceria entre laboratórios públicos nacionais e laboratórios detentores de tecnologia, objetivando a obtenção de conhecimento, capacitação profissional e transferência desta tecnologia. Tais parcerias visam à produção local destes medicamentos estratégicos a um custo reduzido para o Sistema Único de Saúde. Os acordos oferecem vantagens mútuas para o governo e o laboratório detentor da patente do produto biológico: ao primeiro, estabelece-se um fluxo de desenvolvimento biotecnológico, que possibilita potencial redução de custos e autossuficiência na produção, enquanto ao segundo garante-se a exclusividade da venda do produto durante a transferência da tecnologia por um prazo estabelecido.

Humans , Public-Private Sector Partnerships/trends , Biosimilar Pharmaceuticals/standards , Patents as Topic , Brazil , Technology, Pharmaceutical/trends , Technology, Pharmaceutical/statistics & numerical data , Drug Approval/legislation & jurisprudence , Biosimilar Pharmaceuticals/economics
Ciênc. Saúde Colet ; 22(8): 2549-2558, Ago. 2017. tab, graf
Article in English | LILACS | ID: biblio-890421


Abstract Since the enforcement of Generics Act (1999), three types of pharmaceutically equivalent products are marketed in Brazil: innovative reference (REF), "similar" (S) and generic (G) drugs. The S (brand name) and G (generic name) borrow from REF (brand name) clinical data on safety and efficacy and dosage regimen. G (but not S) is bioequivalent to and interchangeable with REF. Starting in 2003, Brazilian Sanitary Surveillance Agency (Anvisa) has required data on relative bioavailability tests (with REF) to approve (or renew registration of) S drugs. In 2014, Anvisa extended interchangeability notion to similar drugs with a "comparable" bioavailability, i.e., an "equivalent" similar drug (EQ). Drugs for chronic diseases and "critical dose medicines" are listed among the EQ drugs approved. Interchangeability of nonbioequivalent medicines raises deep concerns regarding therapeutic failures and adverse events. Concerns are even more worrisome if patients switch from one drug to another during an ongoing treatment for illnesses such as epilepsy, congestive heart failure, hypertension, diabetes and/or substitutable drugs have a narrow therapeutic index.

Resumo A partir da vigência da lei dos genéricos (1999), três tipos de produtos farmaceuticamente equivalentes são comercializados no Brasil: o medicamento inovador de refência (REF), o produto "similar" (S), e o genérico (G). O similar (nome de fantasia) e o genérico (nome genérico) tomam de empréstimo do REF (nome de fantasia) os dados clínicos de segurança e eficácia e a posologia. G (mas não S) é bioequivalente ao, e intercambiável com REF. Desde 2003, a Agência Nacional de Vigilância Sanitária (Anvisa) exige dados de testes de biodisponibilidade relativa para registrar (ou renovar o registro de) medicamentos S. Em 2014, a Anvisa estendeu o conceito de intercambialidade aos medicamentos similares com biodisponibilidade "comparável", i.e., um medicamento similar "equivalente" (EQ). Medicamentos para doenças crônicas e "fármacos de dose crítica" estão listados entre os produtos EQ aprovados. A intercambialidade de medicamentos não-bioequivalentes suscita grande preocupação quanto a falhas terapêuticas e eventos adversos. Os receios são ainda maiores se os pacientes trocam um medicamento por outro durante o tratamento de doenças como epilepsia, insuficiência cardíaca, hipertensão, diabetes e/ou os produtos farmacêuticos substituídos tem um índice terapêutico estreito.

Humans , Drugs, Generic/administration & dosage , Prescription Drugs/administration & dosage , Drug Substitution/methods , Legislation, Drug , Brazil , Biological Availability , Therapeutic Equivalency , Drugs, Generic/adverse effects , Drugs, Generic/pharmacokinetics , Treatment Failure , Drug Approval/legislation & jurisprudence , Prescription Drugs/adverse effects , Prescription Drugs/pharmacokinetics , Drug Substitution/adverse effects , Patient Safety , Therapeutic Index
Cad. Saúde Pública (Online) ; 33(9): e00096716, 2017.
Article in Portuguese | LILACS | ID: biblio-889751


Resumo: No campo farmacêutico, o desenvolvimento de novos fármacos exige um grau sofisticado de entendimento de mecanismos fisiopatológicos, a fim de identificar e caracterizar potenciais alvos biomoleculares e prosseguir com os estudos clínicos. Dentro desse contexto, a proteção dos resultados de Pesquisa & Desenvolvimento é uma etapa vital para garantir o retorno financeiro dos pesados investimentos na área. Uma das estratégias para atingir tal objetivo consiste na exploração de patentes de segundo uso médico, usualmente redigidas no formato "uso do composto X caracterizado pelo fato de ser empregado no preparo de medicamento para a doença Y". Considerando o possível impacto social e a ausência de diretrizes específicas no Brasil, o presente artigo revisa os principais casos relacionados a regimes de dosagem na Europa e analisa os posicionamentos do Escritório Europeu de Patentes (EPO) e judiciários alemão e do Reino Unido sobre os requisitos de patenteabilidade e escopo de proteção, visando a contribuir com o debate técnico sobre o assunto.

Abstract: In the pharmaceutical field, the development of new drugs requires sophisticated understanding of pathophysiological mechanisms in order to identify and characterize potential biomolecular targets and proceed with clinical trials. In this context, protection of research and development results is a vital stage for guaranteeing financial return on the heavy investments in the area. One strategy to achieve this objective is to exploit second-use patents, usually drafted in the format "use of compound X characterized by the fact that it is used in preparing a drug for disease Y". Considering the possible social impact and lack of specific guidelines in Brazil, this article reviews the principal cases related to dosing regimens in Europe and analyzes the positions of the European Patent Office (EPO) and German and UK judiciary systems on the requirements for patentability and scope of protection, aimed at contributing to the technical debate on the topic.

Resumen: En el campo farmacéutico, el desarrollo de nuevos fármacos exige un grado de sofisticación en la comprensión de los mecanismos fisiopatológicos, con el fin de identificar y caracterizar potenciales objetivos biomoleculares y proseguir con los estudios clínicos. Dentro de este contexto, la protección de los resultados de Investigación y Desarrollo es una etapa vital para garantizar el retorno financiero de las costosas inversiones en este área. Una de las estrategias para alcanzar tal objetivo consiste en la explotación de patentes de segundo uso médico, habitualmente redactadas en el formato "uso del compuesto X, caracterizado por el hecho de ser empleado en la preparación del medicamento para la enfermedad Y". Considerando el posible impacto social, y la ausencia de directrices específicas en Brasil, el presente artículo revisa los principales casos relacionados con los regímenes de dosificación en Europa y analiza las posiciones adoptadas por la Oficina Europea de Patentes (EPO) y los sistemas judiciales alemanes y del Reino Unido sobre los requisitos de patentabilidad y alcance de la protección, con el objetivo de contribuir al debate técnico sobre este asunto.

Patents as Topic/legislation & jurisprudence , Drug Approval/legislation & jurisprudence , Legislation, Drug , Brazil , Drug Industry/legislation & jurisprudence , Europe , Drug Dosage Calculations
Salud pública Méx ; 58(1): 71-83, ene.-feb. 2016. ilus, tab
Article in Spanish | LILACS | ID: lil-773571


El dengue es un importante problema de salud pública global, que afecta a América Latina y México. Las medidas de prevención y control centradas en vigilancia epidemiológica y control de vectores han resultado parcialmente efectivas y costosas, por lo que el desarrollo de una vacuna contra el dengue ha creado grandes expectativas entre las autoridades sanitarias y las comunidades científicas en el mundo. Sólo la vacuna CYD-TDV, producida por Sanofi-Pasteur, ha sido evaluada en ensayos clínicos controlados fase 3. No obstante a pesar de la importante contribución que esto significa para el desarrollo de una vacuna contra el dengue, los tres estudios clínicos fase 3 de CYD-TDV y el metaanálisis de seguimiento a largo plazo derivado de los mismos proporcionan evidencia de que esta vacuna tiene una eficacia parcial para proteger contra dengue virológicamente confirmado. Al respecto, surgen cuatro consideraciones: a) eficacia adecuada contra infecciones por virus de dengue (DENV) 3 y 4, menor eficacia contra infecciones por DENV 1 y prácticamente nula protección contra infecciones por DENV 2; b) disminución de la eficacia en individuos seronegativos a dengue al inicio de la vacunación; c) 83 y 90% de protección contra hospitalizaciones y formas de dengue grave, respectivamente, a 25 meses de seguimiento, y d) incremento de hospitalización por dengue, en el grupo de vacunados, en niños menores de nueve años de edad al momento de la vacunación, detectado a partir del tercer año de seguimiento. El beneficio de la vacuna CYD-TDV se puede resumir en la protección contra infecciones por DENV 3 y 4, así como en la protección de hospitalizaciones y casos graves en individuos mayores de nueve años y en quienes han tenido infección previa por dengue, pues funciona principalmente como una vacuna de refuerzo. En esta revisión se identificaron elementos sobre eficacia y seguridad de esta vacuna que deben ser tomados en cuenta ante el potencial registro e inclusión en el programa de vacunación en la población mexicana. La evidencia científica disponible sobre la vacuna CYD-TDV demuestra méritos, pero también da lugar a preguntas relevantes que deberían ser contestadas para evaluar apropiadamente el perfil de seguridad del producto, así como las poblaciones blanco de potencial beneficio. Al respecto, consideramos que sería informativo completar el seguimiento indicado de seis años después de iniciar la vacunación, de acuerdo con el protocolo propuesto en los propios estudios del fabricante como una recomendación de la Organización Mundial de la Salud. Al igual que con cualquier nueva vacuna, el potencial registro e implementación de uso de CYD-TDV en el programa nacional de vacunación de México requiere una definición clara de cuál es el balance entre los beneficios y riesgos esperados. En particular, ante una vacuna con eficacia variable y algunas señales de riesgo, en caso de aprobar el registro, se deben desarrollar protocolos de manejo de riesgos detallados que permitan identificar de manera oportuna cualquier evento de salud asociado con la vacunación.

Dengue is a major global public health problem affecting Latin America and Mexico Prevention and control measures, focusing on epidemiological surveillance and vector control, have been partially effective and costly, thus, the development of a vaccine against dengue has created great expectations among health authorities and scientific communities worldwide. The CYD-TDV dengue vaccine produced by Sanofi-Pasteur is the only dengue vaccine evaluated in phase 3 controlled clinical trials. Notwithstanding the significant contribution to the development of a vaccine against dengue, the three phase 3 clinical studies of CYD-TDV and the meta-analysis of the long-term follow up of those studies, have provided evidence that this vaccine exhibited partial vaccine efficacy to protect against virologically confirmed dengue and lead to four considerations: a) adequate vaccine efficacy against dengue virus (DENV) infections 3 and 4, less vaccine efficacy against DENV 1 and no protection against infection by DENV 2; b) decreased vaccine efficacy in dengue seronegative individuals at the beginning of the vaccination; c) 83% and 90% protection against hospitalizations and severe forms of dengue, respectively, at 25 months follow-up; and d) increased hospitalization for dengue in the vaccinated group, in children under nine years of age at the time of vaccination, detected since the third year of follow-up. The benefit of the CYD-TDV vaccine can be summarized in the protection against infection by DENV 3 and 4, as well as protection for hospitalizations and severe cases in people over nine years, who have had previous dengue infection, working mainly as a booster. In this review we identified elements on efficacy and safety of this vaccine that must be taken into account in the licensing process and potential inclusion in the national vaccination program of Mexico. The available scientific evidence on the CYD-TDV vaccine shows merits, but also leads to relevant questions that should be answered to properly assess the safety profile of the product and the target populations of potential benefit. In this regard we consider it would be informative to complete the 6-year follow-up after starting vaccination, according to the company's own study protocol recommended by the World Health Organization. As with any new vaccine, the potential licensing and implementation of the CYD-TDV as part of Mexico's vaccination program, requires a clear definition of the balance between the expected benefits and risks. Particularly with a vaccine with variable efficacy and some signs of risk, in the probable case of licensing, the post-licensed period must involve the development of detailed protocols to immediately identify risks or any health event associated with vaccination.

Humans , Drug Approval/legislation & jurisprudence , Immunization Programs/legislation & jurisprudence , Dengue/prevention & control , Dengue Vaccines/therapeutic use , Vaccines, Attenuated/therapeutic use , Public Health , Treatment Outcome , Hospitalization , Mexico
Rev. saúde pública (Online) ; 50: 70, 2016. graf
Article in English | LILACS | ID: biblio-962220


ABSTRACT In the US, where registration of lobbyists is mandatory, the pharmaceutical industry and private health-care providers spend huge amounts of money seeking to influence health policies and government decisions. In Brazil, where lobbying lacks transparency, there is virtually no data on drug industry expenditure to persuade legislators and government officials of their viewpoints and to influence decision-making according to commercial interests. Since 1990, however, the Associação da Indústria Farmacêutica de Pesquisa (Interfarma - Pharmaceutical Research Industry Association), Brazilian counterpart of the Pharmaceutical Research and Manufacturers of America (PhRMA), main lobbying organization of the US pharmaceutical industry, has played a major role in the advocacy of interests of major drug companies. The main goals of Interfarma lobbying activities are: shortening the average time taken by the Brazilian regulatory agency (ANVISA) to approve marketing authorization for a new drug; making the criteria for incorporation of new drugs into SUS (Brazilian Unified Health System) more flexible and speeding up technology incorporation; changing the Country's ethical clearance system and the ethical requirements for clinical trials to meet the need of the innovative drug industry, and establishing a National Policy for Rare Diseases that allows a prompt incorporation of orphan drugs into SUS. Although lobbying affects community health and well-being, this topic is not in the public health research agenda. The impacts of pharmaceutical lobbying on health policies and health-care costs are of great importance for SUS and deserve to be investigated.

Humans , Drug Approval/economics , Drug Approval/legislation & jurisprudence , Drug Industry/legislation & jurisprudence , Drug Industry/organization & administration , Lobbying , Persuasive Communication , Brazil , Public Health , Conflict of Interest/economics , Conflict of Interest/legislation & jurisprudence
Rev. bras. epidemiol ; 15(4): 748-760, Dez. 2012. tab
Article in Portuguese | LILACS | ID: lil-668247


Medicamentos genéricos podem ser introduzidos a baixo custo no mercado quando a patente do medicamento inovador expira. Os resultados dos testes que demonstram a segurança e eficácia do produto inovador podem ser extrapolados para o genérico, simplificando sua aprovação. Este paradigma não pode ser aplicado aos biofármacos, grandes moléculas de difícil caracterização, onde pequenas alterações no processo de manufatura influenciam as propriedades biológicas e clínicas do produto e podem resultar em diferenças nos seus perfis de eficácia e segurança. Não sendo possível demonstrar a identidade entre biofármacos, eles não podem ser aprovados como simples genéricos e necessitam regulamentação específica. Neste trabalho foram feitos um levantamento bibliográfico das principais questões envolvidas na aprovação de versões similares de biofármacos e uma análise comparativa da situação regulatória nos principais mercados - EUA e União Europeia - a partir de legislação, projetos de lei, diretrizes e referências técnicas de suas agências regulatórias - FDA (Food and Drug Administration) e EMEA (European Medicines Agency), respectivamente, visando à discussão do caso brasileiro. A partir da legislação e diretrizes estudadas conclui-se que, apesar de Brasil, Europa e Estados Unidos estarem em estágios distintos de definição de sua estrutura regulatória para biossimilares, é possível identificar algumas semelhanças nas abordagens seguidas, como a necessidade de tratamento diferenciado para cada classe de produto (ou um enfoque caso a caso) e de um exercício de comparabilidade passo a passo, cujos resultados definirão a quantidade de dados e estudos clínicos e não clínicos necessários. Entretanto, questões como intercambialidade e substituição automática dos produtos de referência por biossimilares ainda não estão claramente definidas. Do ponto de vista sanitário, a Europa apresenta uma postura mais conservadora, enquanto que EUA e Brasil parecem estar construindo um arcabouço mais flexível. Ao lado das questões sanitárias, entretanto, destacam-se as questões econômicas, de grande importância na legislação dos EUA e Europa e não abordadas na regulamentação brasileira - o que pode trazer insegurança aos produtores interessados neste mercado.

When the patent of a drug expires, low cost generics may be introduced in market. Trial results that demonstrate the safety and efficacy of the reference product can be extrapolated to the generic, simplifying the approval process. This paradigm cannot be applied to biopharmaceutical products, large molecules difficult to be characterized. Minor changes in the production process can influence the biological and clinical properties of the product and result in differences in efficacy and safety profiles. It is not possible to demonstrate the identical nature of biopharmaceuticals arising from different manufacturing sources, so they cannot be approved as simple generics and need specific regulation. A bibliographical survey of the main issues involved in the approval of similar versions of biopharmaceuticals was performed as well as a comparative analysis of the regulatory situation in the largests pharmaceutical markets - U.S. and European Union - based on legislation, draft laws, guidelines and technical references issued by their regulatory agencies - FDA (Food and Drug Administration) and EMEA (European Medicines Agency), respectively, in order enlight the discussion now taking place in Brazil. Based on the laws and guidelines studied, it is concluded that, although Brazil, Europe and the United States are at different stages of setting their regulatory framework for biossimilars, it is possible to identify some similarities in approach, such as the need for different treatment for each product class (or a case by case focus) and a step by step comparison exercise, the results of which will define the amount of data and non-clinical and clinical studies required. However, issues such as interchangeability and automatic substitution of biossimilars for reference products are not yet clearly defined. From the sanitary point of view, Europe has a more conservative posture, while the U.S. and Brazil seem to be building a more flexible framework. Besides the health issues, however, we highlight the economic issues, of great importance in Europe and U.S. legislation, and not addressed in the Brazilian regulation - which can bring insecurity to producers interested in this market.

Humans , Biological Products/pharmacokinetics , Biological Products/therapeutic use , Drug Approval , Brazil , Drug Approval/legislation & jurisprudence , European Union , Licensure/legislation & jurisprudence , Therapeutic Equivalency , United States
Arq. bras. endocrinol. metab ; 55(7): 429-434, out. 2011.
Article in Portuguese | LILACS | ID: lil-607488


Tem se tornado prática comum em nosso país a troca de medicamentos prescritos por outros similares, por produtos genéricos e até mesmo por produtos manipulados, muitas vezes ignorando-se preceitos básicos de bioequivalência, permutabilidade, estabilidade e características específicas do composto farmacêutico. No caso de drogas de índice terapêutico estreito, como a levotiroxina, esses problemas se agravam colocando em sério risco a eficácia do tratamento e a saúde do paciente. Revemos a legislação pertinente ressaltando as características da levotiroxina e os efeitos adversos que limitam a permutabilidade do composto.

The exchange of a prescribed drug by other similar, by generic products and even by custom products has become common practice in our country, often ignoring basic tenets of bioequivalence, interchangeability, stability and characteristics of the pharmaceutical compounds. In the case of drugs of narrow therapeutic index, such as levothyroxine, these problems are intensified, putting the effectiveness of treatment and patient health at serious risk. We review the pertinent legislation, emphasizing the characteristics of levothyroxine and adverse effects that limit the interchangeability of the compound.

Humans , Drug Substitution , Drug Approval/legislation & jurisprudence , Drugs, Generic/pharmacokinetics , Thyroxine/pharmacokinetics , Adverse Drug Reaction Reporting Systems , Brazil , Drug Substitution/adverse effects , Drugs, Generic/adverse effects , Therapeutic Equivalency , Thyroid Hormones/physiology , Thyroxine/adverse effects
Annals of Saudi Medicine. 2008; 28 (1): 33-41
in English | IMEMR | ID: emr-99486


Generic substitution has become a common practice since the late 1970s in the United States. At that time, many of these generics caused bioavailability problems, which fueled suspicions about their efficacy and safety, and the Food and Drug Administration [PDA] standards for bioequivalence. In Saudi Arabia, the increasing number of local products raised several concerns with regard to switching from brands to generics. Our objective was to review and examine the basis of the controversy surrounding brand and generic interchangeability and to explore a practical approach in pursuing a switch. Articles indexed initially under terms such as generic medications, generic substitution, bioequivalence and bioinequivalence were identified. These terms were used to search the indexing service, MEDLINE [1966-2006]. References from the extracted articles, and additional data sources, including the Code of Federal Regulations and Regulatory Guidance from the FDA Center for Drug Evaluation and Research were also reviewed. For most drugs, bioequivalence testing generally should enable clinicians to routinely substitute generic for innovator products. However, for narrow therapeutic, critical dose drugs, or for highly variable drugs, safe switching between products cannot be assured. These drugs need special precautions and blood level monitoring upon switching. FDA firmly believes that approved generic and brand drugs can be dispensed with the full expectation that the consumer will receive the same clinical benefit. Performing the switch process is an advisable practice to reduce health care costs in countries with strong post-marketing surveillance program, but caution is to be exercised when narrow therapeutic index drugs or highly variable drugs are prescribed

Humans , Drugs, Generic/standards , Drugs, Essential/standards , Drug Approval/legislation & jurisprudence , United States Food and Drug Administration
Article in English | IMSEAR | ID: sea-118465


BACKGROUND: New drugs are appearing in the Indian pharmaceutical market every day. To study the trends we analysed the pattern of new drug approvals and introductions in India over the past 15 years (1988-2002). METHODS: Lists of new drugs approved by the Drugs Controller General of India, released half-yearly, were obtained and entered into a computer database. Additional information, such as anatomical therapeutic chemical coding, availability status till 31 December 2002 and source were added to this database before analysing overall time trends and the situation in individual therapeutic categories. RESULTS: Excluding unrecognized and compound formulations and 28 veterinary products, 396 drugs were approved for clinical use during this period. Of these, 315 have also been launched in the market and 5 were subsequently withdrawn. Nervous system-related drugs accounted for the largest number of approvals (82), followed by antimicrobials (73) and cardiovascular drugs (57). Five new antimalarials have emerged but other tropical diseases have been mostly ignored. Eleven vaccines have been added. CONCLUSION: There has been a sharp spurt in the annual number of approvals and introductions. The proliferation of brands and fixed-dose combinations has kept pace with the introduction of new molecules. Unfortunately, most new drugs are not major therapeutic advances. In the context of this rapid proliferation, meeting the information needs of prescribers, establishing an effective nationwide pharmacovigilance system and reorienting the focus of pharmacology education--from information provision to development of self-learning and critical judgement skills-are some issues for concern.

Databases as Topic , Drug Approval/legislation & jurisprudence , Drug Industry/statistics & numerical data , Drug Information Services , Humans , India , Pharmacology/education
La Paz; Bolivia. Instituto Nacional de Seguros de Salud; mar. 2001. 70 p.
Monography in Spanish | LILACS, LIBOCS, LIBOE | ID: lil-300981


Este documento fue elaborado en base al Formulario Terapeútico Nacional, formulario que va a llenar un espacio de mucha importancia en la atención médica a los asegurados y beneficiarios de los distintos entes gestores del Régimen a corto plazo de la Seguridad Social en Bolivia. La normalización de medicamentos con relación a la utilización de genéricos para la adquisición y su clasificación por el uso de medicamentos de consulta externa y hospitalización, permitirá que las Cajas de la Salud hagan uso racional del medicamento y logren, de esta manera, el grado de seguridad del paciente en los tratamientos medicamentosos a los que deben someterse para su recuperación

Catalogs, Drug as Topic , Legislation, Drug , Bolivia , Drug Approval/legislation & jurisprudence , Proprietary Drug Name , Pharmaceutical Preparations/classification , Drug Utilization Review