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Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America.

ABSTRACT: Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product. Biosimilars have the potential to provide savings to healthcare systems and expand patient access to biologics. In Latin American countries, regulatory frameworks for biosimilar approval have been introduced in recent years, and biosimilars of monoclonal antibody and fusion protein therapies are now emerging. However, the situation in this region is complicated by the presence of "non-comparable biotherapeutics" (also known as "intended copies"), which have not been rigorously compared with the originator product. We review the considerations for clinicians in Latin American countries, focusing on monoclonal antibody biosimilars relevant to oncology, rheumatology, gastroenterology, and dermatology.

SUBMITTER: Scheinberg M

PROVIDER: S-EPMC6152448 | biostudies-literature | 2018 Aug/Sep

REPOSITORIES: biostudies-literature

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Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America.

Scheinberg Morton M Pineda Carlos C Castañeda-Hernández Gilberto G Zarbá Juan José JJ Damião Aderson A Arantes Luiz H LH Jacobs Ira I

mAbs 20180829 6

Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product. Biosimilars have the potential to provide savings to healthcare systems and ...[more]

PMID: 30156950

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Project description:PurposeDespite the call to increase the number of radiation oncologists in Latin America, the quality, similarity, and number of residency training programs are unknown. We seek to describe the current state of residency programs in radiation oncology in Latin America.Methods and materialsLatin American Residents in Radiation Oncology performed a cross-sectional analysis of universities and training centers for radiation oncologists in Latin America. Latin American Residents in Radiation Oncology members identified and contacted current residents and specialists at each center to obtain information and documents that described their training curricula.ResultsAs of 2020, 13 of 23 (56.5%) Latin American countries have radiation oncology training. Seventy-three training centers were identified (59 active and 14 inactive), associated with 28 universities. On average, each active center trains 2.6 new residents per year, and in total, 156 residents are trained annually. The average length of training programs is 3.6 years. Brazil and Mexico comprise 31 (52.5%) and 7 (11.9%) of active programs, respectively, and 64 (41.8%) and 50 (32.7%) residents, respectively. Training is available in 38 cities in 13 countries, and outside Brazil and Mexico, only 13 cities in 11 countries (9 capitals and 4 noncapital cities). Individualized curriculum documents were provided by 20 (83.3%) of 24 non-Brazilian programs, while 1 standardized guideline was provided for Brazilian training programs. These demonstrated variation between subjects taught, their devoted time, outside specialty rotations, and experiences in modern techniques. Seventy-five percent include volumetric modulated arc therapy, 70% stereotactic radiosurgery, and 55% stereotactic body radiation therapy training. One-hundred percent include gynecologic brachytherapy education and <50% brachytherapy education in other disease sites.ConclusionsTraining is highly centralized in capital cities. The number of trainees is insufficient to close the current human resource divide but is limited by available job openings. Over 50% of training programs now include technological training in stereotactic radiosurgery, stereotactic body radiation therapy, or volumetric modulated arc therapy; however, substantial variation still exists. The development of radiation oncology specialists must be improved and modernized to address the escalating demand for cancer care.

Project description:Background and aimOne of the most impacted regions by the pandemic globally, Latin America is facing socioeconomic and health-care challenges that can potentially affect disease outcomes. Recent data suggest that inflammatory bowel disease (IBD) patients do not have an increased risk of the development of COVID-19 complications. However, the impact of COVID-19 on IBD patients living in least developed areas remains to be fully elucidated. This study aims to describe the outcomes of IBD patients diagnosed with COVID-19 in countries from Latin America based on data from the SECURE-IBD registry.MethodsPatients from Latin America enrolled in the SECURE-IBD registry were included. Descriptive analyses were used to summarize clinical and sociodemographic characteristics. The studied outcomes were (i) a composite of need for intensive care unit admission, ventilator use, and/or death (primary outcome) and (ii) a composite of any hospitalization and/or death (secondary outcome). Multivariable regression was used to identify risk factors of severe COVID-19.ResultsDuring the study period, 230 cases (Crohn's disease: n = 115, ulcerative colitis: n = 114, IBD-unclassified [IBD-U]: n = 1) were reported to the SECURE-IBD database from 13 different countries. Primary outcome was observed in 17 (7.4%) patients, and the case fatality rate was 1.7%. In the adjusted multivariable model, the use of systemic corticosteroids (odds ratio [OR] 10.97; 95% confidence interval [CI]: 3.44-34.99) was significantly associated with the primary outcome. Older age (OR 1.03; 95% CI: 1.00-1.05), systemic corticosteroids (OR 9.33; 95% CI: 3.84-22.63), and the concomitant presence of one (OR 2.14; 95% CI: 0.89-5.15) or two (OR 10.67; 95% CI: 1.74-65.72) comorbidities were associated with the outcome of hospitalization or death.ConclusionInflammatory bowel disease patients with COVID-19 in Latin America appear to have similar outcomes to the overall global data. Risk factors of severe COVID-19 are similar to prior reports.

Project description:BackgroundDespite progress that has been made in the treatment of many immune-mediated inflammatory diseases (IMIDs), there remains a need for improved treatments. Randomised controlled trials (RCTs) provide the highest form of evidence on the effectiveness of a potential new treatment regimen, but they are extremely expensive and time consuming to conduct. Consequently, much focus has been given in recent years to innovative design and analysis methods that could improve the efficiency of RCTs. In this article, we review the current use and future potential of these methods within the context of IMID trials.MethodsWe provide a review of several innovative methods that would provide utility in IMID research. These include novel study designs (adaptive trials, Sequential Multi-Assignment Randomised Trials, basket, and umbrella trials) and data analysis methodologies (augmented analyses of composite responder endpoints, using high-dimensional biomarker information to stratify patients, and emulation of RCTs from routinely collected data). IMID trials are now well-placed to embrace innovative methods. For example, well-developed statistical frameworks for adaptive trial design are ready for implementation, whilst the growing availability of historical datasets makes the use of Bayesian methods particularly applicable. To assess whether and how these innovative methods have been used in practice, we conducted a review via PubMed of clinical trials pertaining to any of 51 IMIDs that were published between 2018 and 20 in five high impact factor clinical journals.ResultsAmongst 97 articles included in the review, 19 (19.6%) used an innovative design method, but most of these were relatively straightforward examples of innovative approaches. Only two (2.1%) reported the use of evidence from routinely collected data, cohorts, or biobanks. Eight (9.2%) collected high-dimensional data.ConclusionsApplication of innovative statistical methodology to IMID trials has the potential to greatly improve efficiency, to generalise and extrapolate trial results, and to further personalise treatment strategies. Currently, such methods are infrequently utilised in practice. New research is required to ensure that IMID trials can benefit from the most suitable methods.

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Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America.

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Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America.

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