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1.
Expert Opin Biol Ther ; 24(7): 627-635, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38962838

RESUMEN

PURPOSE: Evaluate the type and quantity of quality information (i.e. Chemistry, Manufacturing, and Control) requested by the US FDA and EMA in queries pertaining to biosimilar applications. METHODS: Numbers/types of queries received following regulatory submissions (FDA/EMA, n = 7/n = 5) for seven biosimilars (PF-filgrastim [Nivestym], PF-rituximab [Ruxience®], PF-trastuzumab [Trazimera®], PF-bevacizumab [Zirabev®], PF-pegfilgrastim [Nyvepria®], PF-adalimumab [Abrilada™/Amsparity®], PF-infliximab [Ixifi]) from a single product portfolio were analyzed considering published regulatory authority (RA) guidance and in relation to sections/subsections of Module 3: Quality from the Common Technical Document regulatory dossier and topics based on keyword assignment. RESULTS: Queries were most frequently assigned (FDA/EMA %, range) to Drug Substance Manufacture (subsection 3.2.S.2; 21-35%/13-50%), Control of Drug Substance (3.2.S.4; 3-11%/5-17%), Drug Product Pharmaceutical Development (3.2.P.2; 1-12%/1-15%) and Manufacture (3.2.P.3; 17-41%/2-13%), and Analytical Similarity (3.2.R; 4-21%/4-20%). The proportion of Drug Substance and Drug Product queries was significantly different between RAs (n1 = 952, n2 = 468, p-value <0.001; two-sample proportion z-test). Topic assignments included: Control (12-27%/12-28%), Manufacturing (56-72%/34-66%), Stability (1-12%/2-24%), Biosimilarity (5-16%/5-25%), and Container Closure (0-3%/0-9%). CONCLUSION: The focus of both RAs on topics related to manufacturing and controls is valuable in understanding expectations for scientific and technical content related to gaining biosimilar approval.


Asunto(s)
Biosimilares Farmacéuticos , Industria Farmacéutica , United States Food and Drug Administration , Biosimilares Farmacéuticos/normas , Humanos , Estados Unidos , Industria Farmacéutica/legislación & jurisprudencia , Industria Farmacéutica/normas , Aprobación de Drogas/legislación & jurisprudencia , Control de Calidad , Unión Europea
2.
PLoS One ; 17(1): e0262537, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35015783

RESUMEN

Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018-August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.


Asunto(s)
Factores Biológicos/normas , Biosimilares Farmacéuticos/normas , Industria Farmacéutica/normas , Prescripciones de Medicamentos/normas , Sustitución de Medicamentos/normas , Testimonio de Experto/métodos , Farmacovigilancia , Factores Biológicos/administración & dosificación , Biosimilares Farmacéuticos/administración & dosificación , Aprobación de Drogas , Humanos , Estados Unidos , United States Food and Drug Administration
3.
Drug Discov Today ; 27(1): 65-81, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-34461236

RESUMEN

Biological drugs or biopharmaceuticals off patent open a large market for biosimilars and biobetters, follow-on biologics. Biobetters, in particular, are new drugs designed from existing ones with improved properties such as higher selectivity, stability, half-life and/or lower toxicity/immunogenicity. Glycosylation is one of the most used strategies to improve biological drugs, nonetheless bioconjugation is an additional alternative and refers to the covalent attachment of polymers to biological drugs. Extensive research on novel polymers is underway, nonetheless PEGylation is still the best alternative with the longest clinical track record. Innovative trends based on genetic engineering techniques such as fusion proteins and PASylation are also promising. In this review, all these alternatives wereexplored as well as current market trends, legislation and future perspectives.


Asunto(s)
Productos Biológicos , Biosimilares Farmacéuticos , Productos Biológicos/farmacología , Productos Biológicos/normas , Biosimilares Farmacéuticos/farmacología , Biosimilares Farmacéuticos/normas , Quimioterapia/tendencias , Humanos , Ingeniería Metabólica/métodos , Ingeniería de Proteínas/métodos , Mejoramiento de la Calidad
5.
Biologicals ; 73: 41-56, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-34593306

RESUMEN

The majority of recombinant mAb products contain heterogeneous charge variants, commonly the result of post-translational modifications occurring during cell culture and accumulated during production, formulation and storage. MB02 is a biosimilar mAb to bevacizumab. Similarity data of charge variants for biosimilars against its reference products must be generated to demonstrate consistency in product quality and to ensure efficacy and safety. The goal of this work was to isolate seven charge variants of MB02 and Avastin® by semi-preparative cation exchange chromatography followed by purity test and extended analytical characterization to prove similarity. Although poor purity obtained for minor variants complicated data interpretation, an in-depth insight into the charge variants pattern of MB02 compared to Avastin® was obtained, contributing to a better understanding of modifications associated to microheterogeneity. To our knowledge, this is the first comparative analytical study of individual charge variants of a bevacizumab biosimilar following a head-to head approach and the most comprehensive N-glycosylation assessment of IgG1 charge variants. Although modifications related to N- and C-terminal, N-glycans, size heterogeneity or deamidation were specifically enriched among low abundant charge variants, they did not affect binding affinity to VEGF or FcRn and in vitro potency compared with the main species or unfractionated material.


Asunto(s)
Bevacizumab/química , Biosimilares Farmacéuticos , Biosimilares Farmacéuticos/química , Biosimilares Farmacéuticos/normas , Glicosilación , Inmunoglobulina G
6.
Clin Pharmacol Ther ; 110(5): 1311-1317, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-34472087

RESUMEN

The relevance of biological therapies for an increasing number of conditions is on the rise. Following the expiry of the initial period of market exclusivity, many of these successful therapies have seen the arrival of biosimilars on the market. The clear identification of the precise medicine responsible for an adverse drug reaction (ADR) report is an important element for pharmacovigilance, allowing timely detection of potential product-specific safety signals. We looked at the identifiability of biologicals up to the level of commercial product name in ADR reports received from European clinical practice between 2011 and December 2019. A good level of identification (91.5%) was observed overall, but at the same time a downward trend was observed in the last 5 years. This reduction in the level of identifiability of biological products (originators and biosimilars) at the commercial name level in general was driven by five widely used substances, whereas the identification of all other biologics stayed consistent over time (at over 90%). We observed that those five substances were used mostly within oncology. The introduction of the first biosimilar in the market did not appear to affect their identifiability. These results show that although the general level of identification at the commercial product name level in ADRs in Europe is robust and generally stable over time, decreasing trends can be down to a few commonly used substances, which need to be monitored to reverse the trend.


Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos , Factores Biológicos/efectos adversos , Biosimilares Farmacéuticos/efectos adversos , Bases de Datos Factuales , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Unión Europea , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Antineoplásicos Inmunológicos/efectos adversos , Antineoplásicos Inmunológicos/normas , Factores Biológicos/normas , Biosimilares Farmacéuticos/normas , Bases de Datos Factuales/estadística & datos numéricos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/diagnóstico , Unión Europea/estadística & datos numéricos , Humanos , Farmacovigilancia , Medición de Riesgo/métodos , Medición de Riesgo/estadística & datos numéricos , Rituximab/efectos adversos
7.
Dig Dis Sci ; 66(8): 2513-2532, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-34176024

RESUMEN

The introduction of therapeutic monoclonal antibodies directed against tumor necrosis factor-α has revolutionized the treatment of inflammatory bowel disease (IBD) by improving quality of life, decreasing the frequency and length of hospital admissions, and reducing corticosteroid use. Nevertheless, biologics are very expensive, substantially contributing to the cost of care for patients with IBD. To reduce this cost and improve treatment access, biosimilars, which are therapeutic monoclonal antibodies (biologicals) similar to but not identical to the reference biologic, were introduced. Despite their potential benefits, the adoption and uptake of biosimilars have varied considerably across the USA and Europe. Here, we highlight the current biosimilar therapeutic landscape, discuss barriers to their use, and provide an overview of published studies evaluating the efficacy and safety of biosimilars in IBD.


Asunto(s)
Anticuerpos Monoclonales/uso terapéutico , Biosimilares Farmacéuticos/uso terapéutico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Biosimilares Farmacéuticos/normas , Humanos
8.
Front Immunol ; 12: 636420, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33936049

RESUMEN

The expanded availability of adalimumab products continues to widen patient access and reduce costs with substantial benefit to healthcare systems. However, the long-term success of these medicines is highly dependent on maintaining consistency in quality, safety and efficacy while minimizing any risk of divergence during life-cycle management. In recognition of this need and demand from global manufacturers, the World Health Organization (WHO) Expert Committee on Biological standardization established the WHO 1st International standard (IS) for Adalimumab (coded 17/236) in October 2019 with a defined unitage ascribed to each of the individual bioactivities evaluated in the study namely, TNF-α binding, TNF-α neutralization, complement dependent cytotoxicity and antibody-dependent cellular cytotoxicity. For development of the IS, two candidate standards were manufactured as per WHO recommendations. Analysis of extensive datasets generated by testing of a common set of samples including the candidate standards by multiple stakeholders including regulatory agencies using their own qualified assays in a large international collaborative study showed comparable biological activity for the tested candidates for the different activities. Use of a common standard significantly decreased the variability of bioassays and improved agreement in potency estimates. Data from this study clearly supports the utility of the IS as an important tool for assuring analytical assay performance, for bioassay calibration and validation, for identifying and controlling changes in bioactivity during life-cycle management and for global harmonization of adalimumab products. In addition, in a separate multi-center study which included involvement of hospital and clinical diagnostic laboratories, the suitability of the adalimumab IS for therapeutic drug monitoring assays was examined by analysis of data from testing of a common blind coded panel of adalimumab spiked serum samples representative of the clinical scenario along with the IS and in-house standards in diverse immunoassays/platforms. Both commercially available and in-house assays that are routinely used for assessing adalimumab trough levels were included. Excellent agreement in estimates for adalimumab content in the spiked samples was observed regardless of the standard or the method with inter-laboratory variability also similar regardless of the standard employed. This data, for the first time, provides support for the extended applicability of the IS in assays in use for therapeutic drug monitoring based on the mass content of the IS. The adalimumab IS, in fulfilling clinical demand, can help toward standardizing and harmonizing clinical monitoring assays for informed clinical decisions and/or personalized treatment strategies for better patient outcomes. Collectively, a significant role for the adalimumab IS in assuring the quality, safety and efficacy of adalimumab products globally is envisaged.


Asunto(s)
Adalimumab/uso terapéutico , Bioensayo/normas , Biosimilares Farmacéuticos/uso terapéutico , Monitoreo de Drogas/normas , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Adalimumab/efectos adversos , Animales , Especificidad de Anticuerpos , Biosimilares Farmacéuticos/efectos adversos , Biosimilares Farmacéuticos/normas , Células CHO , Cricetulus , Células HEK293 , Humanos , Células Jurkat , Control de Calidad , Estándares de Referencia , Equivalencia Terapéutica , Inhibidores del Factor de Necrosis Tumoral/efectos adversos , Inhibidores del Factor de Necrosis Tumoral/normas , Factor de Necrosis Tumoral alfa/inmunología , Células U937 , Organización Mundial de la Salud
9.
Reprod Biol Endocrinol ; 19(1): 51, 2021 Apr 02.
Artículo en Inglés | MEDLINE | ID: mdl-33794909

RESUMEN

BACKGROUND: Live birth has increasingly been identified as the standard clinical approach to measure the success of medically assisted reproduction (MAR). However, previous analyses comparing biosimilar preparations of follitropin alfa versus the reference product (GONAL-f®, Merck KGaA, Darmstadt, Germany or GONAL-f® RFF; EMD Serono, Inc., Rockland, MA), have had insufficient power to detect differences in clinically meaningful outcomes such as live birth. METHODS: Medline, Embase, the Cochrane Library, Web of Science and clinical trial registries were searched for randomised controlled trials (RCTs) and conference abstracts comparing biosimilar follitropin alfa versus the reference product in controlled ovarian stimulation (COS) cycles published before 31 October 2020. Only studies in humans and publications in English were included. Retrieved studies were screened independently by two authors based on titles and abstracts, and then by full text. INCLUSION CRITERIA: RCTs comparing follitropin alfa biosimilar preparations with the reference product in infertile patients of any age, with any type of infertility for any duration, undergoing COS for the purposes of MAR treatment (including frozen cycles). The primary outcome was live birth. Combined data for biosimilar preparations were analysed using a fixed-effects model. RESULTS: From 292 unique records identified, 17 studies were included in the systematic review, representing five unique RCTs that were included in the meta-analysis. Rates of live birth (RR = 0.83, 95% CI 0.71, 0.97; 4 RCTs, n = 1881, I2 = 0%), clinical pregnancy (RR = 0.82, 95% CI 0.72, 0.94; 4 RCTs, n = 2222, I2 = 0%) and ongoing pregnancy (RR = 0.81, 95% CI 0.68, 0.96; 4 RCTs, n = 1232, I2 = 0%) were significantly lower with biosimilar preparations versus the reference product. Rates of cumulative live birth and cumulative clinical pregnancy were also significantly lower with biosimilars versus the reference product. There was high risk of publication bias. CONCLUSIONS: This meta-analysis included data from RCTs evaluating the efficacy and safety of the biosimilar follitropin alfa preparations and demonstrated lower probability of live birth and pregnancy (ongoing and clinical) in couples treated with biosimilar preparations compared with the reference product. This study provides more insight into the differences between biosimilar r-hFSH preparations and the reference product than previously reported. TRIAL REGISTRATION: Registration number: CRD42019121992 .


Asunto(s)
Biosimilares Farmacéuticos/administración & dosificación , Hormona Folículo Estimulante Humana/administración & dosificación , Infertilidad/tratamiento farmacológico , Proteínas Recombinantes/administración & dosificación , Técnicas Reproductivas Asistidas , Biosimilares Farmacéuticos/normas , Femenino , Hormona Folículo Estimulante Humana/normas , Humanos , Infertilidad/diagnóstico , Infertilidad/epidemiología , Masculino , Embarazo , Índice de Embarazo/tendencias , Proteínas Recombinantes/normas , Técnicas Reproductivas Asistidas/normas
11.
Biologicals ; 69: 30-37, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33454195

RESUMEN

Biosimilar approval relies on the comparability of quality attributes (QAs), for which information can be derived from regulatory or scientific communities. Limited information is known about whether these sources are consistent with or complementary to each other. The consistency and complementarity of QA reporting in biosimilarity assessments for adalimumab biosimilars approved by the European Medicines Agency in European public assessment reports (EPARs) and scientific publications was assessed. A classification of 77 different QAs (53 structural and 24 functional attributes) was used to assess the types of and information on QAs reported. Six adalimumab biosimilars were analyzed, for which the number of QAs reported in EPARs and publications varied (range = 47 [61%]-60 [78%]). The proportion of QAs consistently reported in both sources varied (range = 28%-75%) among biosimilars; functional QAs (mean = 21 QAs [88%]; range = 19-23) were more consistently reported than structural QAs (mean = 33 QAs [62%]; range = 27-34). The EPARs frequently reported biosimilarity interpretation without providing test results (9-57 QAs in EPARs versus 0-8 QAs in publications), whereas publications frequently reported both test results and interpretations (13-40 QAs in publications versus 0-3 QAs in EPARs). Both sources provided information on the biosimilarity of QAs in a complementary manner and the same biosimilarity interpretation of test results for reported QAs (mean = 90%; range = 78%-100%), with a small discrepancy in biosimilarity interpretations of a few clinically relevant QAs related to post-translation modifications and biological activity. Comprehensive reporting of QAs can contribute to an improved understanding of the role of structural and functional attributes in establishing biosimilarity and the mechanism of action of biological substances in general.


Asunto(s)
Adalimumab , Biosimilares Farmacéuticos , Adalimumab/química , Biosimilares Farmacéuticos/normas , Aprobación de Drogas
12.
Ann N Y Acad Sci ; 1491(1): 42-59, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33222245

RESUMEN

The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices. Despite this effort, a recent WHO survey (conducted in 2019-2020) has revealed four main remaining challenges: unavailable/insufficient reference products in the country; lack of resources; problems with the quality of some biosimilars (and even more with noninnovator products); and difficulties with the practice of interchangeability and naming of biosimilars. The following have been identified as opportunities/solutions for regulatory authorities to deal with the existing challenges: (1) exchange of information on products with other regulatory authorities and accepting foreign licensed and sourced reference products, hence avoiding conducting unnecessary (duplicate) bridging studies; (2) use of a "reliance" concept and/or joint review for the assessment and approval of biosimilars; (3) review and reassessment of the products already approved before the establishment of a regulatory framework for biosimilar approval; and (4) setting appropriate regulatory oversight for good pharmacovigilance, which is essential for the identification of problems with products and establishing the safety and efficacy of interchangeability of biosimilars.


Asunto(s)
Biosimilares Farmacéuticos/normas , Aprobación de Drogas , Farmacovigilancia , Guías como Asunto , Intercambio de Información en Salud , Humanos , Encuestas y Cuestionarios , Organización Mundial de la Salud
13.
Regul Toxicol Pharmacol ; 117: 104768, 2020 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-32861742

RESUMEN

Biological medicines have significantly altered treatment for many patients with chronic diseases such as cancers, autoimmune diseases, and diabetes. However, the high cost of biological medicines has limited patients' access to them. Iraq is one of the countries that have decided to increase access to these medicines through biosimilars, which are copies of originator biological medicines. Prior to 2019, the Iraqi National Regulatory Authority (NRA) had no clear guidelines in place for biosimilars uptake. Therefore, approvals of many biosimilars were delayed. As a response to that, a new pivotal committee was found within this authority, and the first version of Iraqi basis and guidelines for the approval of biosimilars was enacted. With the implementation of the Iraqi biosimilars guidelines and escalating the cooperation within the Iraqi NRA, many benefits have been attained in a short time including the approval of many essential biosimilar products which has resulted in a total cost savings estimated to exceed 50 million USD in just the year 2020. However, there are still some barriers towards making the utmost benefit from biosimilars in Iraq, such as lack of familiarity of these products among the Iraqi health care providers which requires appropriate biosimilars-awareness enhancement strategies.


Asunto(s)
Biosimilares Farmacéuticos/normas , Ahorro de Costo/legislación & jurisprudencia , Aprobación de Drogas/legislación & jurisprudencia , Farmacovigilancia , Animales , Biosimilares Farmacéuticos/economía , Ahorro de Costo/métodos , Aprobación de Drogas/métodos , Humanos
14.
PDA J Pharm Sci Technol ; 74(5): 563-570, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32295861

RESUMEN

Chemistry, manufacturing, and control postapproval changes are an intrinsic part of the life cycle of pharmaceutical products. In this paper, the authors examined the potential impact of such changes on the product quality, safety, and efficacy of biologics. Comparability studies and more specifically analytical comparability are introduced as one of the tools that can support both biomanufacturers and health agencies in ensuring that patient safety and product safety and efficacy is maintained through the proposed changes. Together with a scientific risk-based review approach based on product and process knowledge and the definition of acceptance criteria that will ensure that the product is "essentially similar", what constitutes a holistic comparability study is detailed. ICH Guidelines principles and definitions are used throughout the paper to aid the reader with other appropriate references. Finally, two case studies are presented: change to the manufacturing facility of the drug substance, and change to the manufacturing process of a drug substance intermediate and manufacturing facility.


Asunto(s)
Productos Biológicos/análisis , Biosimilares Farmacéuticos/análisis , Preparaciones Farmacéuticas/análisis , Control de Calidad , Tecnología Farmacéutica , Productos Biológicos/normas , Biosimilares Farmacéuticos/normas , Aprobación de Drogas , Guías como Asunto , Humanos , Seguridad del Paciente , Preparaciones Farmacéuticas/normas , Vigilancia de Productos Comercializados , Gestión de Riesgos , Tecnología Farmacéutica/normas , Equivalencia Terapéutica
15.
BioDrugs ; 34(3): 297-306, 2020 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-32266678

RESUMEN

Since the first approval of a biosimilar medicinal product in 2006, scientific understanding of the features and development of biosimilar medicines has accumulated. This review scrutinizes public information on development programs and the contribution of the clinical studies for biosimilar approval in the European Union (EU) and/or the United States (US) until November 2019. The retrospective evaluation of the programs that eventually obtained marketing authorization and/or licensure revealed that in 95% (36 out of 38) of all programs, the comparative clinical efficacy studies confirmed similarity. In the remaining 5% (2 out of 38), despite meeting efficacy outcomes, the biosimilar candidates exhibited clinical differences in immunogenicity that required changes to the manufacturing process and additional clinical studies to enable biosimilar approval. Both instances of clinical differences in immunogenicity occurred prior to 2010, and the recurrence of these cases is unlikely today due to state-of-the-art assays and improved control of process-related impurities. Biosimilar candidates that were neither approved in the EU nor in the US were not approved due to reasons other than clinical confirmation of efficacy. This review of the development history of biosimilars allows the proposal of a more efficient and expedited biosimilar development without the routine need for comparative clinical efficacy and/or pharmacodynamic studies and without any compromise in quality, safety, or efficacy. This proposal is scientifically valid, consistent with regulation of all biologics, and maintains robust regulatory standards in the assessment of biosimilar candidates. Note: The findings and conclusion of this paper are limited to biosimilar products developed against the regulatory standards in the EU and the US.


Asunto(s)
Biosimilares Farmacéuticos , Desarrollo de Medicamentos/normas , Biosimilares Farmacéuticos/efectos adversos , Biosimilares Farmacéuticos/normas , Biosimilares Farmacéuticos/uso terapéutico , Aprobación de Drogas , Unión Europea , Humanos , Estados Unidos , United States Food and Drug Administration
16.
J Biopharm Stat ; 30(3): 521-536, 2020 05 03.
Artículo en Inglés | MEDLINE | ID: mdl-32089068

RESUMEN

As indicated in a recent published draft guidance on comparative analytical assessment, the United States (US) Food and Drug Administration (FDA) seems to suggest the use of quality range (QR) method for analytical similarity evaluation. It is a concern that the use of QR method for analytical similarity evaluation could potentially approve biological products which are not deemed biosimilar to the reference biological products. In this article, the limitations and potential risk for the use of the QR method for analytical similarity evaluation are discussed. Alternatively, two modified versions of the QR method, which are referred to as effect size (ES) mQR and plausibility interval (PI) mQR methods are suggested. The performance and statistical properties of the mQR methods are evaluated via extensive clinical trial simulation under various scenarios. The results indicate that the modified versions of the QR method not only overcome the limitations of the QR method for analytical similarity evaluation, but also can potentially help in detecting reference product changes during manufacturing process.


Asunto(s)
Biosimilares Farmacéuticos/normas , Simulación por Computador/estadística & datos numéricos , Simulación por Computador/normas , Aprobación de Drogas/estadística & datos numéricos , United States Food and Drug Administration/estadística & datos numéricos , United States Food and Drug Administration/normas , Biosimilares Farmacéuticos/uso terapéutico , Aprobación de Drogas/métodos , Humanos , Método de Montecarlo , Estados Unidos
17.
J Natl Compr Canc Netw ; 18(1): 12-22, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31910384

RESUMEN

Management of febrile neutropenia (FN) is an integral part of supportive care for patients undergoing cancer treatment. The NCCN Guidelines for Hematopoietic Growth Factors provide suggestions for appropriate evaluation, risk determination, prophylaxis, and management of FN. These NCCN Guidelines are intended to guide clinicians in the appropriate use of growth factors for select patients undergoing treatment of nonmyeloid malignancies. These NCCN Guidelines Insights highlight important updates to the NCCN Guidelines regarding the incorporation of newly FDA-approved granulocyte-colony stimulating factor biosimilars for the prevention and treatment of FN.


Asunto(s)
Biosimilares Farmacéuticos/uso terapéutico , Neutropenia Febril Inducida por Quimioterapia/tratamiento farmacológico , Factores de Crecimiento de Célula Hematopoyética/uso terapéutico , Neoplasias/tratamiento farmacológico , Guías de Práctica Clínica como Asunto , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Biosimilares Farmacéuticos/economía , Biosimilares Farmacéuticos/normas , Neutropenia Febril Inducida por Quimioterapia/etiología , Aprobación de Drogas , Costos de los Medicamentos , Educación Médica Continua , Factores de Crecimiento de Célula Hematopoyética/economía , Factores de Crecimiento de Célula Hematopoyética/normas , Humanos , Oncología Médica/educación , Oncología Médica/normas , Neoplasias/sangre , Oncólogos/educación , Organizaciones sin Fines de Lucro/normas , Factores de Riesgo , Estados Unidos , United States Food and Drug Administration/legislación & jurisprudencia
18.
BioDrugs ; 34(2): 225-233, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-31925703

RESUMEN

BACKGROUND: Biosimilars must meet stringent regulatory requirements, both at the time of authorization and during their lifecycle. Yet it has been suggested that divergence in quality attributes over time may lead to clinically meaningful differences between two versions of a biologic. Therefore, this study investigated the batch-to-batch consistency across a range of parameters for released batches of the etanercept biosimilar (SB4) and infliximab biosimilar (SB2). METHODS: SB4 (Benepali®) and SB2 (Flixabi®) were both developed by Samsung Bioepis and are manufactured in Europe by Biogen at their facility in Hillerød, Denmark. A total of 120 batches of SB4 and 25 batches of SB2 were assessed for consistency and compliance with specified release parameters, including purity, post-translational glycosylation (SB4 only), protein concentration, and biological activity. RESULTS: The protein concentration, purity, tumor necrosis factor-α (TNF-α) binding, and TNF-α neutralization of all batches of SB4 and SB2 were within the strict specification limits set by regulatory agencies, as was the total sialic acid (TSA) content of all batches of SB4. CONCLUSIONS: Quality attributes of SB4 and SB2 batches showed little variation and were consistently within the rigorous specifications defined by regulatory agencies.


Asunto(s)
Antiinflamatorios no Esteroideos/normas , Antirreumáticos/normas , Biosimilares Farmacéuticos/normas , Etanercept/normas , Tecnología Farmacéutica/normas , Antiinflamatorios no Esteroideos/química , Antiinflamatorios no Esteroideos/inmunología , Antiinflamatorios no Esteroideos/farmacología , Antirreumáticos/química , Antirreumáticos/farmacología , Biosimilares Farmacéuticos/química , Biosimilares Farmacéuticos/farmacología , Etanercept/química , Etanercept/farmacología , Europa (Continente) , Glicosilación , Humanos , Infliximab/química , Infliximab/farmacología , Ácido N-Acetilneuramínico , Control de Calidad , Tecnología Farmacéutica/métodos , Factor de Necrosis Tumoral alfa
19.
Br J Ophthalmol ; 104(1): 2-7, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31315829

RESUMEN

PURPOSE: This article aims to analyse the key regulatory guidelines across the globe concerning biosimilars. MATERIALS AND METHODS: Review of the current literature. RESULTS: Biosimilars are well regulated with the majority of regulators having enforced the guidelines for the development and approval, and new biosimilar drugs are appearing on the horizon to provide a therapeutic option to a wider population base because of its cost-effectiveness and proven safety. Due to their extensive analytical data, clinical data and pharmacovigilance studies, their development should not be considered similar to generic drugs. CONCLUSION: This review discusses the biosimilars, their regulation globally and their difference from generics from ophthalmic perspective.


Asunto(s)
Biosimilares Farmacéuticos/normas , Control de Medicamentos y Narcóticos/organización & administración , Oftalmopatías/tratamiento farmacológico , Biosimilares Farmacéuticos/uso terapéutico , Medicamentos Genéricos/normas , Humanos , Oftalmología/normas , Farmacovigilancia , Guías de Práctica Clínica como Asunto
20.
Biologicals ; 63: 33-38, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31862294

RESUMEN

The expiry of patents protecting the manufacture and sale of therapeutic darbepoetin products is expected to lead to the emergence of biosimilar products. In response to this, the first World Health Organization (WHO) International Standard (IS) for darbepoetin has been developed. A lyophilized preparation of darbepoetin, coded 17/204, was evaluated in an international collaborative study, the results of which suggest that the candidate preparation is suitable to serve as an IS. This material defines the International Unit (IU) of in vitro biological activity of darbepoetin and should be used to calibrate of in vitro potency assays of darbepoetin preparations. It is envisaged that widespread use of the IS will promote the consistency and harmonization of darbepoetin in vitro bioassay measurements in laboratories worldwide. Each ampoule contains 100,000 IU of darbepoetin activity. The IU is not intended to revise product labelling or dosing requirements, decisions regarding which lie solely with the regulatory authority. Additionally, the IS is not intended to define the specific activity of darbepoetin, as this may differ between products in the future. Finally, the IS is not intended to serve any regulatory role in defining biosimilarity (i.e. as a reference medicinal product).


Asunto(s)
Biosimilares Farmacéuticos/normas , Darbepoetina alfa/normas , Organización Mundial de la Salud , Calibración , Humanos , Estándares de Referencia
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