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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.

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.

Background and purposeDistal ACA aneurysms remain difficult to treat with endovascular therapy, but improved technology and experience allows for the treatment of some of these aneurysms with excellent results. The purpose of this study was to assess the status of endovascular treatment of distal ACA aneurysms by comparing our results with recent endovascular and microsurgical series of distal ACA aneurysms.Materials and methodsBetween 2000 and 2008, a total of 22 consecutive patients (14 women; mean age, 58.4 years) with distal ACA aneurysms underwent coil placement at Barrow Neurological Institute. Clinical presentations, radiographic findings, endovascular management, and outcomes were reviewed retrospectively.ResultsOf the 22 patients, 13 (59%) presented with subarachnoid hemorrhage. Six patients were HH grade I or II, 1 was grade III, 5 were grade IV, and 1 was grade V. Frontal lobe hematomas occurred in 5 patients with ruptured aneurysms. The mean aneurysm size was 7.5 mm (range, 2.8-25 mm); 55% were smaller than 7 mm. Twelve aneurysms (55%) arose from the origin of the callosomarginal artery (55%). Complete occlusion was achieved in 50% of the cases and near-complete occlusion in 45%. The few periprocedural complications included 1 retroperitoneal hematoma and 1 intraoperative rupture. Four patients had thromboembolic events adequately treated intraprocedurally with abciximab. No deaths occurred in the patients treated.ConclusionsThe characteristics of the patients and aneurysms treated in our series were comparable to previous reports of endovascular treatment of ACA aneurysms with respect to rupture status. Periprocedural morbidity and mortality rates in our series fared well compared with previous reports, as did our combined rate of complete or near-complete occlusions. Recent advances in endovascular devices and techniques have improved outcomes of distal ACA aneurysms.