Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison.

Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice.

Fractura de clavícula distal con cortical superior indemne: cirugía mínimamente invasiva / Distal clavicle fracture with intact upper cortex: minimally invasive surgery

INTRODUCCIÓN Las fracturas de clavícula distal desplazadas son manejadas generalmente de manera quirúrgica dada la alta probabilidad de no-unión con el tratamiento ortopédico. El propósito de este trabajo es evaluar el uso del sistema de fijación con doble botón cortical para la reducción y estabilización de la fractura de clavícula distal que presenten indemnidad de la cortical superior. MÉTODOS: Estudio retrospectivo observacional clínico-imagenológico de pacientes con fractura desplazada de clavícula distal operados con técnica mínimamente invasiva mediante reducción con sistema de fijación con doble botón cortical. Se describe como criterio radiológico de "Cortical Superior Indemne (CSI)" la presencia del rasgo de fractura a 1cm o más, hacia distal desde el tubérculo conoide, identificándose ese criterio como característica necesaria para la indicación del tratamiento propuesto. Se describen las complicaciones post-operatorias, progresión radiológica y resultados funcionales. RESULTADOS: 21 pacientes fueron tratados con esa técnica con un seguimiento promedio de 23,4 meses. No hubo casos de no unión, infección o herida dehiscente y ningún paciente requirió el retiro del dispositivo. Se encontró un Simple Shoulder Test (SST) promedio de 79,4 (66 - 91,7) y QuickDASH de 11 (6,8 - 15,9). El 87,5% de las fracturas desplazadas de clavícula distal tenían indemnidad de la cortical superior. CONCLUSIÓN: La técnica mínimamente invasiva para la reducción y fijación de la fractura de clavícula distal desplazada con botones corticales es una alternativa simple, reproducible, con pocas complicaciones y excelentes resultados funcionales.

BACKGROUND: Displaced distal clavicle fractures are commonly managed through surgery due to a high probability of nonunion with conservative treatments. The purpose of this study is to evaluate the use of Flip-buttons as a minimally invasive method for fixing and stabilizing displaced distal clavicle fractures when the upper cortical it́s intact. METHODS: A retrospective observational study of radiological and clinical results of patients with displaced distal clavicle fracture that were treated with the Flip-button technique. The indication for using this surgical method was based on the radiological criteria of "Intact Upper Cortical (IUC)" described by the authors as the presence of the fracture 1cm or more, distally to de conoid tubercle. Post-operative complications, radiologic and functional progress were recorded. RESULTS: 21 patients were treated with this technique, all with complete bony union. No patients presented infection or wound dehiscence and implant removal was not necessary in any case. The mean follow-up was of 23,4 months. The mean score in Simple Shoulder Test (SST) was 79,4 (66 - 91,7) and a mean QuickDASH of 11 (6,8 - 15,9). 87,5% of all the displaced distal clavicle fractures had IUC. CONCLUSION: The minimally invasive technique for the reduction and fixation of the displaced distal clavicle fracture with cortical buttons is a simple and reproducible alternative, with few complications and excellent functional results.