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1.
Artigo em Alemão | MEDLINE | ID: mdl-33034693

RESUMO

Biosimilars are medicinal products that are highly similar to approved biopharmaceuticals. Biosimilars enable patient access to biological therapies that would otherwise be restricted or delayed due to cost reasons. After the successful introduction of low-molecular biosimilars in 2006, highly complex monoclonal antibodies have also been available since 2013 as biosimilars for treating autoimmune diseases and oncologic indications. In principle, the biosimilar concept can be applied to all well-characterized biologicals; in the future, blood clotting factors or drugs containing nucleic acids, such as DNA or RNA gene therapy or mRNA vaccines, will also be an option for biosimilar development.In some instances, biosimilarity can be demonstrated by physicochemical and functional similarity, and additional comparative clinical efficacy and safety studies have been considered no longer necessary for several product categories in recent years. Switching a patient from a reference drug to a biosimilar or from one biosimilar to another (interchangeability) has so far been considered harmless. Since February 2020, there has been a provisional decision in Germany that patients should be switched according to an economic prescription method. Further scientific findings on the interchangeability of biosimilars and experiences with the supply practices of biosimilars should be collected and evaluated.In this article, the current situation regarding marketing authorizations of biosimilars in the European Union is reviewed. The role of clinical trials for biosimilars is presented, and challenges of biosimilar development and views on interchangeability are discussed.


Assuntos
Medicamentos Biossimilares , Anticorpos Monoclonais , Medicamentos Biossimilares/uso terapêutico , União Europeia , Alemanha , Humanos
2.
Artigo em Alemão | MEDLINE | ID: mdl-33090245

RESUMO

In the German healthcare system, immunotherapies have been well established for years. Currently there are over 100 registrations of monoclonal antibodies (MABs). In recent years, new immunotherapeutic approaches became available, amongst them checkpoint inhibitors and CAR­T cells in oncology. Increasing expenditures of the German statutory health insurance (SHI) system are regarded with concerns. This article presents an overview of the development and status of prescriptions and sales of selected immunotherapeutics in Germany. Data from 2015-2019 were analyzed, primarily from the GKV-Arzneimittel-Schnellinformation (GAmSi) and the consultancy IQVIA.In the group of older MABs, such as immunosuppressive and antineoplastic agents, biosimilars led to a (temporary) increase of applications, but reimbursement amounts are decreasing. Instruments of the SHI system like drug agreements, reference prices, and individual discount contracts intervene as expenditure control. Checkpoint inhibitors clearly show increasing prescriptions and expenditures. Finally, the CAR­T cells are indeed very expensive treatments, but are currently not that important due to the limited number of applications. In addition, the exemption from VAT of 19% and the signed discount agreements between suppliers and sickness funds reduce the burden. In 2015 and 2019, the net expenditures on drugs and surgical dressings accounted for 17.2% of the total expenditures on benefits of the SHI system. Should the expenditures on drugs increase overproportionately in the future, the German SHI system will be able to counteract with already available or new instruments, supported by the legislator. Manufacturers and the SHI system should develop joint actions to achieve solutions for new treatment approaches.


Assuntos
Medicamentos Biossimilares , Medicamentos Biossimilares/uso terapêutico , Assistência à Saúde , Alemanha , Gastos em Saúde , Imunoterapia , Programas Nacionais de Saúde
4.
Medicine (Baltimore) ; 99(30): e21151, 2020 Jul 24.
Artigo em Inglês | MEDLINE | ID: mdl-32791688

RESUMO

BACKGROUND: The introduction of biological disease-modifying anti-rheumatic drugs (bDMARDs) into clinical practice has dramatically improve the clinical outcomes of individuals with rheumatoid arthritis (RA). However, bDMARDs are associated with high costs, which has resulted in restricted treatment access and a burden on medical insurance finances. Although biosimilars offer cost-saving, their effectiveness and safety must be established in Post-Marketing Surveillance (PMS). Infliximab (IFX), a chimeric monoclonal antibody to TNF-alpha, is the first bDMARD; its biosimilar, CT-P13, is the first biosimilar DMARD approved for RA treatment in Japan. We will evaluate whether switching from originator IFX to CT-P13 is not inferior for maintaining non-clinical relapse to continued treatment with originator IFX in RA patients achieving clinical remission. METHODS/DESIGN: This study is an interventional, multicenter, open-label, single-arm against historical control and noninferiority clinical trial with a 24-week follow-up. Eighty RA patients who are treated by originator IFX for ≥24 weeks and are achieving clinical remission will be included. Patients will be switched to CT-P13 with the unchanged dosing regimen. We will evaluate disease activity by measuring clinical disease activity indices and by using musculoskeletal ultrasound (MSUS). The primary endpoint is the ratio of patients who experience a nonclinical relapse during the study period. Important secondary endpoints are the changes from the baseline of the MSUS scores. We will also comprehensively analyze the serum levels of many biomarkers such as cytokines and chemokines. DISCUSSION: The study results are expected to show the noninferiority of switching to CT-P13 over the continuation of originator IFX. The strength of this study is its prospective evaluation of therapeutic efficacy using not only clinical disease activity indices but also MSUS to accurately and objectively evaluate disease activity at the joint level among patients drawn from multiple centers with a standardized evaluation by MSUS. We will explore whether parameters at baseline can predict a nonclinical relapse after switching from originator IFX to CT-P13 by integrating multilateral assessments, i.e., clinical disease activity indices, MSUS findings, and serum biomarkers. TRIAL REGISTRATION: This study was registered in the Japan Registry of Clinical Trials (https://jrct.niph.go.jp) on October 11, 2019 as jRCTs071190030.


Assuntos
Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/uso terapêutico , Quimiocinas/sangue , Infliximab/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Artrite Reumatoide/sangue , Artrite Reumatoide/diagnóstico por imagem , Biomarcadores/sangue , Substituição de Medicamentos , Estudos de Equivalência como Asunto , Humanos , Japão , Quimioterapia de Manutenção , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Índice de Gravidade de Doença , Ultrassonografia , Adulto Jovem
5.
Artigo em Inglês | MEDLINE | ID: mdl-32796549

RESUMO

Although biosimilars have been part of clinical practice for more than a decade, healthcare professionals (HCPs) do not fully accept them. This is because of the perception that biosimilars may not be like their originators in terms of quality, safety, and efficacy. This study aims to evaluate the current knowledge and attitudes of healthcare professionals toward biosimilar prescription, and to elaborate on their concerns. We reviewed the literature using PubMed, Cochrane Library, and Science Direct electronic databases in the period from 2018 to 2020. The knowledge and confidence of healthcare professionals vary between countries, between clinical profiles and between studies. Although most of the healthcare professionals had a positive attitude to prescribing biosimilars, they would still prefer to prescribe them in initial treatment. Generally, HCPs were against multiple switches and substitution of biosimilars at the pharmacy level. HCP's key concern was interchangeability, with eventual consequences on the clinical outcome of patients. HCPs still approach biosimilars with caution and stigma. HCPs need to have an unbiased coherent understanding of biosimilars at clinical, molecular and regulatory levels. It was also observed that most of their concerns are more theoretical than science-based. Physicians are in an excellent position to accept biosimilars, but they need the additional support of regulatory authorities to approve and take into consideration the available scientific data regarding biosimilars.


Assuntos
Atitude do Pessoal de Saúde , Medicamentos Biossimilares , Pessoal de Saúde , Humanos , Médicos
6.
Yonsei Med J ; 61(8): 712-719, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32734735

RESUMO

PURPOSE: There has been no extensive study to compare the efficacy between rituximab originator (Mabthera®) and its biosimilar (Truxima®) for microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA). Here, we investigated the clinical effects of rituximab on poor outcomes of MPA and GPA in Korean patients, and compared those between Mabthera® and Truxima®. MATERIALS AND METHODS: We retrospectively reviewed the medical records of a total of 139 patients, including 97 MPA patients and 42 GPA patients. At diagnosis, antineutrophil cytoplasmic antibody positivity and comorbidities were assessed. During follow-up, all-cause mortality, relapse, end-stage renal disease, cerebrovascular accident and acute coronary syndrome were evaluated as poor outcomes. In this study, rituximab was used as either Mabthera® or Truxima®. RESULTS: The median age at diagnosis was 60.1 years and 46 patients were men (97 MPA and 42 GPA patients). Among poor outcomes, patients receiving rituximab exhibited a significantly lower cumulative relapse-free survival rate compared to those not receiving rituximab (p=0.002). Nevertheless, rituximab use did not make any difference in other poor outcomes of MPA and GPA except for relapse, which might be a rebuttal to the fact that rituximab use after relapse eventually led to better prognosis. There were no significant differences in variables at diagnosis and during follow-up between patients receiving Mabthera® and those receiving Truxima®. Patients receiving Truxima® exhibited a similar pattern of the cumulative survival rates of each poor outcome to those receiving Mabthera®. CONCLUSION: Truxima® prevents poor outcomes of MPA and GPA as effectively as does Mabthera®.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Granulomatose com Poliangiite/tratamento farmacológico , Poliangiite Microscópica/tratamento farmacológico , Rituximab/uso terapêutico , Feminino , Granulomatose com Poliangiite/mortalidade , Humanos , Masculino , Poliangiite Microscópica/mortalidade , Pessoa de Meia-Idade , Prognóstico , Recidiva , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do Tratamento
8.
Medicine (Baltimore) ; 99(32): e21480, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32769882

RESUMO

BACKGROUND: The introduction of biological disease-modifying anti-rheumatic drugs into clinical practice has dramatically improved the clinical outcomes of individuals with rheumatoid arthritis (RA). We are conducting the IFX-SIRIUS STUDY I that evaluates whether switching from originator infliximab (IFX) to its biosimilar, CT-P13, is not inferior in maintaining nonclinical relapse to continue treatment with originator IFX in patients with RA achieving clinical remission. It is the next great issue whether disease activity can be maintained in good condition after discontinuation of CT-P13 because no evidence is available regarding the clinical value of discontinuing biosimilars in patients with RA. Thus, we will evaluate whether a condition without clinical relapse will be maintained after discontinuation of CT-P13 in patients with RA, achieving clinical remission or low disease activity during the IFX-SIRIUS STUDY I. METHODS/DESIGN: This study is an interventional, multicenter, open-label, single-arm clinical trial with a 48-week follow-up. Patients with RA who are treated with CT-P13 and sustained nonclinical relapse during the IFX-SIRIUS STUDY I will be included. Patients will discontinue CT-P13 after the study period of the IFX-SIRIUS STUDY I. We will evaluate disease activity by clinical disease activity indices and musculoskeletal ultrasound (MSUS). The primary endpoint is the proportion of patients who do not have clinical relapse during the study period. Important secondary endpoints are the changes from the baseline of the MSUS scores. We will also comprehensively analyze the serum levels of multiple biomarkers, such as cytokines and chemokines. In addition, if a clinical relapse occurs in patients after the discontinuation of CT-P13, we will evaluate the effectiveness and safety of restarting CT-P13. DISCUSSION: The study results are expected to show the clinical benefit of the discontinuation of CT-P13 and effectiveness and safety of restarting CT-P13 after clinical relapse. The strength of this study is to prospectively evaluate the therapeutic effectiveness by not only clinical disease activity indices but also standardized MSUS findings in multiple centers. We will explore whether parameters at baseline can predict a nonclinical relapse after the discontinuation of CT-P13 by integrating multilateral assessments, that is, patient's characteristics, clinical disease activity indices, MSUS findings, and serum biomarkers. TRIAL REGISTRATION: This study was registered in the Japan Registry of Clinical Trials (https://jrct.niph.go.jp) on April 20, 2020 as jRCTs071200007.


Assuntos
Anticorpos Monoclonais/administração & dosagem , Antirreumáticos/administração & dosagem , Artrite Reumatoide/patologia , Medicamentos Biossimilares/administração & dosagem , Substituição de Medicamentos , Infliximab/administração & dosagem , Adulto , Artrite Reumatoide/diagnóstico por imagem , Artrite Reumatoide/tratamento farmacológico , Biomarcadores/análise , Estudos de Equivalência como Asunto , Feminino , Humanos , Quimioterapia de Indução , Japão , Masculino , Recidiva , Resultado do Tratamento , Ultrassonografia
10.
Farm. hosp ; 44(3): 100-108, mayo-jun. 2020. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-192340

RESUMO

El proceso de aprobación de los biosimilares de anticuerpos monoclonales en la Unión Europea está dirigido a descartar la presencia de diferencias significativas con el biológico original en los atributos de calidad, eficacia, inmunogenicidad y seguridad. Proporciona además la justificación para extrapolar la evidencia obtenida con un biosimilar en al menos una indicación al resto de indicaciones aprobadas para su biológico original, simplificando el programa de desarrollo de los biosimilares. Los biosimilares de anticuerpos monoclonales disponibles en la Unión Europea para el tratamiento de enfermedades inflamatorias y del cáncer han cumplido todos los requerimientos establecidos para la aprobación, y en muchos casos disponen de evidencia adicional. Además, los datos de uso en la vida real están confirmando la seguridad y eficacia de estos fármacos en las distintas patologías en las que se están utilizando. En España, varias sociedades médicas avalan el proceso regulatorio de los biosimilares y reconocen su papel en la eficiencia del sistema sanitario. No obstante, todavía existen algunas barreras que limitan su uso. La aplicación de diferentes medidas a nivel de paciente, prescriptor, institucional y nacional podría aumentar la penetración de los biosimilares, liberando recursos que podrían invertirse en otras terapias y, potencialmente, favorecer la innovación


The approval pathway for biosimilars of monoclonal antibodies in the European Union is aimed at ruling out the presence of significant differences with the original biological in quality attributes, efficacy, immunogenicity and safety. It also provides the rationale for extrapolating the evidence obtained with a biosimilar in at least one indication to the rest of the approved indications of its original biological, thus simplifying the deve-lopment programme of biosimilars. Biosimilars of monoclonal antibodies available in the European Union for the treatment of inflammatory diseases and cancer have fulfilled all the requirements for approval, and many of them have additional evidence available. Moreover, real world data confirms the safety and efficacy of these drugs in the indications they are being used for. In Spain, many scientific societies endorse the regulatory pathway of biosimilars and acknowledge their role in the efficiency of the healthcare system. Even so, some barriers remain that limit their use. The implementation of different measures at the patient, prescriber, institutional, and national levels might increase the penetration of biosimilars, freeing up resources that may be invested in other therapies and, potentially, boost innovation


Assuntos
Humanos , Anticorpos Monoclonais/uso terapêutico , Inflamação/tratamento farmacológico , Neoplasias/tratamento farmacológico , Medicamentos Biossimilares/normas , Produtos Biológicos/normas , Medicamentos Biossimilares/uso terapêutico , União Europeia , Aprovação de Drogas/legislação & jurisprudência
12.
Global Health ; 16(1): 50, 2020 06 05.
Artigo em Inglês | MEDLINE | ID: mdl-32503571

RESUMO

This commentary re-examines a recent article by Labonté et al on the recent changes to two relevant provisions relating to patent rights in the final version of the United-States-Mexico-Canada Agreement (USMCA). Although the USMCA's final revised version does not add more pharmaceutical patent protection than those that already exist in the three trading partners, the agreement has done little to enhance access to generic medicines and biosimilars.


Assuntos
Medicamentos Biossimilares , Saúde Pública , Canadá , Comércio , Cooperação Internacional , México , Estados Unidos
13.
Artigo em Inglês | MEDLINE | ID: mdl-32526943

RESUMO

Biologic drugs represent a large and growing portion of health expenditures. Increasing the use of biosimilars is a promising option for controlling spending growth in pharmaceutical care. Amid the considerable uncertainty concerning physicians' decision to prescribe biosimilars, explicit cost control measures may help increase biosimilar use. We analyze the role of regional cost control measures for biosimilars and their association with physician prescriptions in ambulatory care in Germany. We collect data on cost control measures implemented by German physician associations and national claims data on statutory health insurance covering 2009 to 2015. We perform panel regressions that include time and physician fixed effects to identify the average associations between cost control measures and biosimilar share/use while controlling for unobserved physician heterogeneity, patient structure, and socioeconomic factors. We identify 44 measures (priority prescribing, biosimilar quota) for erythropoiesis-stimulating substances, filgrastim, and somatropin. Estimates of cost control measures and their consequences for biosimilar share and use are heterogeneous by drug, measure type, and physician group. Across specialists, biosimilar quotas accounted for 5.13% to 9.75% of the total average biosimilar share of erythropoiesis-stimulating substances. Explicit quota regulations are more effective than priority prescribing. Regional variation in biosimilar use can be partly attributed to the presence of cost control measures.


Assuntos
Medicamentos Biossimilares , Controle de Custos , Custos de Medicamentos , Médicos , Idoso , Filgrastim , Alemanha , Humanos , Masculino
14.
Gan To Kagaku Ryoho ; 47(3): 397-401, 2020 Mar.
Artigo em Japonês | MEDLINE | ID: mdl-32381902

RESUMO

Several biosimilars have appeared in cancer treatment. They should contribute to the reduction of medical cost. However, in Japan, a suspicion of medical staffs and patients to biosimilars and an obstruction of High-Cost Medical Expense Benefit to the burden reduction of patients suppress the use of biosimilars. Recently, several guidelines declare to promote the use of biosimilars. High-quality biosimilars are also going to be developed by next generation biotechnologies. The positive selection of biosimilars hopefully contribute to patients and national medical economy. In this review, we mention about the current subjects and future prospects of biosimilars.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Neoplasias/tratamento farmacológico , Humanos
18.
AAPS J ; 22(3): 72, 2020 05 15.
Artigo em Inglês | MEDLINE | ID: mdl-32415524

RESUMO

A recent paper reviewed clinical studies intending to bridge a prefilled syringe (PFS) to an autoinjector (AI) based on regulatory submission packages sent to the FDA. An AI generally uses the identical PFS within the AI and the AI typically results in a more consistent injection than can be achieved with a PFS. It is noted that several studies submitted to the FDA did not demonstrate bioequivalence (BE) between the PFS and AI, yet the products were approved anyway. The author of this Commentary believes that formal BE studies should not be required for such bridging studies.


Assuntos
Medicamentos Biossimilares , Seringas , Injeções Subcutâneas , Equivalência Terapêutica
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