An introduction to biosimilar cancer therapeutics: definitions, rationale for development and regulatory requirements

Buske, Christian; Kwon, Hyuk‐Chan; Yoon, Sang Wook

doi:10.2217/fon-2017-0153

Cited by 40 publications

(48 citation statements)

References 25 publications

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“…Considering the clinical and economic burden of biological and non-biological targeted therapies in cancer treatment, it is necessary to explore how these drugs are used in routine care and how they affect the sustainability of the National Health Services (NHSs). Once a biological drug loses its patent, the corresponding biosimilar may enter the market, thus guaranteeing an average 20–30% lower purchase cost than originators [ 4 ]. To date, the only biosimilar that has been approved by the European Medicines Agency (EMA) for cancer treatment is rituximab (2017), while trastuzumab and bevacizumab biosimilars are still currently under review [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

Prevalence of Use and Cost of Biological Drugs for Cancer Treatment: A 5-Year Picture from Southern Italy

et al. 2017

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Background and ObjectivesConsidering the clinical and economic burden of biological and non-biological targeted therapies in cancer treatment, it is necessary to explore how these drugs are used in routine care in Italy and how they affect the sustainability of the National Health Services. This study aimed to investigate the prevalence of use and costs of biological and non-biological targeted therapies for cancer treatment in a general population of Southern Italy in the years 2010–2014.MethodsThis was a retrospective, observational study using data from the healthcare administrative databases of Messina Province for the years 2010–2014. In this study, users of biological and non-biological targeted therapies for cancer treatment were characterized and the prevalence of use and costs were calculated over time. The potential impact of biosimilars on the expenditure was also estimated.ResultsOf a population of 653,810 residents in the Messina area during the study years, 2491 (0.4%) patients received at least one study drug. The most frequently used were monoclonal antibodies (mAbs) (n = 1607; 64.5%) and tyrosine kinase inhibitors (TKIs) (n = 609; 24.4%). mAbs were mainly used by females (60.3%) for metastasis due to an unspecified primary tumor, lymphomas, or breast cancer (24.2, 16.7, and 13.7%, respectively). Most users of small molecules were males (56.3%) being treated for multiple myeloma, metastasis due to unspecified primary tumor, leukemia, and lung cancer (13.1, 12.6, 9.5, and 8.9%, respectively). During the study years, the prevalence of use doubled from 0.9 to 1.8 per 1000 inhabitants; likewise, the related expenditure grew from €6.6 to €13.6 million. Based on our forecasts, this expenditure will grow to €25 million in 2020. Assuming a 50% biosimilar uptake (trastuzumab and rituximab), a potential yearly saving of almost €1 million may be achieved.ConclusionsIn recent years, the use and costs of biological and non-biological targeted therapies in cancer patients dramatically increased in a large population from Southern Italy. This trend may be counterbalanced by adopting biosimilars once they are available. Claims databases represent a valid tool to monitor the uptake of newly marketed biological drugs and biosimilars as well as other non-biological targeted therapies.Electronic supplementary materialThe online version of this article (doi:10.1007/s40261-017-0591-3) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

Prevalence of Use and Cost of Biological Drugs for Cancer Treatment: A 5-Year Picture from Southern Italy

et al. 2017

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“…Estas variações não acontecem da mesma maneira nos medicamentos biossimilares, pois nestes medicamentos, pequenas diferenças estão associadas ao fato destes serem produzidos a partir de organismos vivos. Assim, o conceito de medicamento genérico não se aplica aos biossimilares (23)(24) .…”

Section: Diferenças Entre Medicamentos Biológicos Biossimilares De unclassified

Biofármacos no Brasil: uma revisão do processo de regulamentação / Biopharmaceuticals in Brazil: a review of the regulatory process

Privato

Martínez

Schmidt

2020

Arq Med Hosp Fac Cienc Med Santa Casa São Paulo

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Introdução: Medicamentos biológicos são produzidos utilizando-se a tecnologia do DNA recombinante. São classificados em hormônios, hemoderivados, fatores de coagulação e anticoagulantes, fatores de crescimento hematopoiético, enzimas, citocinas, medicamentos imunológicos variados, anticorpos monoclonais e terapêuticas de base celular. Esses produtos aparecem como a maior fonte de inovação da indústria farmacêutica, destacando-se como medicamentos essenciais para o tratamento de doenças graves ou raras. O vencimento de patentes de medicamentos biológicos proporciona a incorporação de biotecnologias por meio do desenvolvimento da produção brasileira de biossimilares, contribuindo para o crescimento do mercado destes produtos no Brasil, com custos reduzidos. A Resolução da Diretoria Colegiada RDC 55/2010 da Agência Nacional de Vigilância Sanitária (ANVISA) é o principal marco regulatório brasileiro sobre registro de medicamentos biológicos e biossimilares. Objetivos: Este trabalho de revisão bibliográfica descreve as etapas da produção de medicamentos biológicos e biossimilares e sua introdução no mercado brasileiro. Método: Foi realizada uma busca de informações na literatura científica utilizando-se as seguintes bases de dados: NCBI, Scielo, Google Scholar e ANVISA. Resultados: A aprovação dos biossimilares no Brasil possibilitou uma mudança no cenário global no tratamento de doenças crônicas e raras, notadamente em benefício a pacientes oncológicos. Conceitos científico-regulatórios, como o plano de desenvolvimento por comparabilidade, extrapolação de indicações, substituição, intercambialidade e imunogenicidade atualmente devem ser conhecidos por todos os profissionais de saúde para que o uso dos medicamentos biológicos originadores e biossimilares se estabeleça por meio de práticas adequadas e racionais. Conclusão: A regulamentação de produtos biológicos e biossimilares no Brasil, pela ANVISA, é robusta e está muito bem alinhada com as agências reguladoras da Europa (EMA) e dos Estados Unidos (FDA).Palavras Chave: Biofármacos, Medicamentos biológicos, Biossimilares, Produção de medicamentos, Regulamentação, BrasilABSTRATCIntroduction: Biological drugs are produced using recombinant DNA technology. They are classified into hormones, blood products, coagulation factors and anticoagulants, hematopoietic growth factors, enzymes, cytokines, various immunological drugs, monoclonal antibodies and cell-based therapies. These products appear as the major source of innovation in the pharmaceutical industry, standing out as essential medicines for the treatment of serious or rare diseases. The expiration of patents for biological medicines provides the incorporation of biotechnologies through the development of the Brazilian production of biosimilars, contributing to the growth of the market of these products in Brazil, with reduced costs. Resolution RDC 55/2010 Collegiate Board of the National Health Surveillance Agency (ANVISA) is the main Brazilian regulatory framework on registration of biological and biosimilar medicines. Objectives: This literature review describes the stages of production of biological and biosimilar medicines, until the introduction in the Brazilian market. Method: A search for information was carried out in the scientific literature using the following databases: NCBI, Scielo, Google Scholar and ANVISA. Results: The approval of biosimilars in Brazil enabled a change in the global scenario in the treatment of chronic and rare diseases, notably for the benefit of cancer patients. Scientific-regulatory concepts, such as the development plan for comparability, extrapolation of indications, substitution, interchangeability and immunogenicity, must be known by all health professionals so that the use of originating and biosimilar biological drugs is established through appropriate and rational practices. Conclusion: The regulation of biologicals and biosimilars in Brazil, by ANVISA, is robust and it is very well aligned with the regulatory agencies in Europe (EMA) and the United States (FDA).Keywords: Biopharmaceuticals, Biological medicines, Biosimilars, Products production, Regulation, Brazil

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“…These factors, coupled with the high costs of manufacturing biologics and macro- and micro-economic factors resulting in higher health care costs, have led to a rise in cancer care spending. 7 , 11 In high-income countries, the costs of delivering cancer care are outstripping national budgets, and sustainability of health care financing remains a key public policy concern. 12 …”

Section: The High Cost Of Cancer Carementioning

confidence: 99%

“…As costs of biologics are high, long-term treatment of patients with biologics can be a chronic burden to health care systems. 7 …”

Section: Introductionmentioning

confidence: 99%

The role of biosimilars in value-based oncology care

Patel¹,

Arantes²,

Tang³

et al. 2018

CMAR

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Biopharmaceuticals (biologics) represent one of the fastest growing sectors of cancer treatment. They are recommended for treating underlying cancer and as supportive care for management of treatment side effects. Given the high costs of cancer care and the need to balance health care provision and associated budgets, patient access and value are the subject of discussion and debate in the USA and globally. As the costs of biologics are high, biosimilars offer the potential of greater choice and value, increased patient access to treatment, and the potential for improved outcomes. Value-based care aims to improve the quality of care, while containing costs. The Centers for Medicare & Medicaid Services (CMS) has developed value-based care programs as alternatives to fee-for-service reimbursement, including in oncology, that reward health care providers with incentive payments for improving the quality of care they provide. It is anticipated that CMS payments in oncology care will be increasingly tied to measured performance. This review provides an overview of value-based care models in oncology with a focus on CMS programs and discusses the contribution of biosimilars to CMS value-based care objectives. Biosimilars may provide an important tool for providers participating in value-based care initiatives, resulting in cost savings and efficiencies in the delivery of high-value care through expanded use of biologic treatment and supportive care agents during episodes of cancer care.

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An introduction to biosimilar cancer therapeutics: definitions, rationale for development and regulatory requirements

Cited by 40 publications

References 25 publications

Prevalence of Use and Cost of Biological Drugs for Cancer Treatment: A 5-Year Picture from Southern Italy

Prevalence of Use and Cost of Biological Drugs for Cancer Treatment: A 5-Year Picture from Southern Italy

Biofármacos no Brasil: uma revisão do processo de regulamentação / Biopharmaceuticals in Brazil: a review of the regulatory process

The role of biosimilars in value-based oncology care

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