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.

Larvicidal Potential of the Halogenated Sesquiterpene (+)-Obtusol, Isolated from the Alga Laurencia dendroidea J. Agardh (Ceramiales: Rhodomelaceae), against the Dengue Vector Mosquito Aedes aegypti (Linnaeus) (Diptera: Culicidae).

Dengue is considered a serious public health problem in many tropical regions of the world including Brazil. At the moment, there is no viable alternative to reduce dengue infections other than controlling the insect vector, Aedes aegypti Linnaeus. In the continuing search for new sources of chemicals targeted at vector control, natural products are a promising alternative to synthetic pesticides. In our work, we investigated the toxicity of a bioactive compound extracted from the red alga Laurencia dendroidea J. Agardh. The initial results demonstrated that crude extracts, at a concentration of 5 ppm, caused pronounced mortality of second instar A. aegypti larvae. Two molecules, identified as (-)-elatol and (+)-obtusol were subsequently isolated from crude extract and further evaluated. Assays with (-)-elatol showed moderate larvicidal activity, whereas (+)-obtusol presented higher toxic activity than (-)-elatol, with a LC50 value of 3.5 ppm. Histological analysis of the larvae exposed to (+)-obtusol revealed damage to the intestinal epithelium. Moreover, (+)-obtusol-treated larvae incubated with 2 µM CM-H2DCFDA showed the presence of reactive oxygen species, leading us to suggest that epithelial damage might be related to redox imbalance. These results demonstrate the potential of (+)-obtusol as a larvicide for use against A. aegypti and the possible mode of action of this compound.

Public sector implementation strategies to approach the judicialization of health care: a systematic review protocol.

BACKGROUND: The judicialization of health care can be understood as a societal response to pressing healthcare needs, which probably are not being adequately addressed by the current healthcare system. This phenomenon increases the strain on service resources, both in the health sector and in the judiciary system as well, demanding an institutional reorganization to manage judicial actions. It is believed that each institution has developed strategies for coping with the problem in isolation and with little public disclosure. The purpose of this review will be to identify institutional strategies implemented and to investigate their effects in approaching the judicialization of health care. METHODS: Electronic searches will be conducted up to December 2021 on 11 databases, supplemented with gray literature and references lists of secondary studies. The descriptor "judicialization of health" will be the basis for conducting the main research. Studies describing any strategy implemented by public institutions to approach the judicialization of health care will be included. Results related to the quality of services provided by the implemented strategy reported in the studies and those that report accessibility, usability, and potential adverse effects or harms caused by the implemented strategy will be investigated. In addition, it will be explored if there have been changes related to the value or characteristics of health litigation. Two reviewers will independently screen all citations, abstract data, and full-text papers. The risk of bias in each study will be appraised using a tool suggested by Cochrane Effective Practice and Care Organization Group (EPOC). Subsequently, the reviewers will also extract the data of interest and classify the findings of these studies according to their performance at the institutional level. The results obtained will be described as a narrative synthesis. DISCUSSION: This review may provide evidence on the effects of the strategies implemented to approach the judicialization of health care. It will potentially benefit health care and legal professionals, decision-makers, and researchers by identifying the types and characteristics of strategies that have the potential to improve service delivery in the future. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020160608.

Strategies to Approach Medicines Litigation: An Action Research Study in Brazil.

Background: In the last decades, litigation has been increasingly used to access medicines in Brazil. This phenomenon has led to the development of diverse strategies to reduce its negative impact on the organization of pharmaceutical services. In spite of that, managers still face difficulties dealing with lawsuits. Objective: This study aims to report the planning and implementation of strategies to approach medicines litigation in a municipality located in the southeast region of Brazil. Methods: Mixed methods were employed through an action research cycle. A network coordination team included researchers from university and municipal managers. The scenario analysis comprised the characterization of pharmaceutical services and the profile of medicines lawsuits. Afterward, strategies were planned to deal with the central problem identified. The action plan involved educational outreach visits and distribution of printed materials for health professionals, evaluated through opinion survey. Group conversations were conducted with the users of the public health system, followed by thematic analysis of reports. Results: The characterization of pharmaceutical services in the municipality revealed that treatments supplied were in accordance with the National Medicines Policy. In addition, a sector was implemented to attend demands for non-incorporated medicines. In spite of the services available, the characterization of lawsuits indicated that the main claimants were users of the public health system, requiring non-incorporated medicines, with therapeutic alternatives available. Thus, educational outreach visits were held in 14 health units (23 physicians in total). Everyone who answered the evaluation declared that they were very satisfied with the approach. Group conversations with the users of the health system reached 227 participants in total. In regard to users' perception about pharmaceutical services, thematic analysis of reports identified three main categories including aspects related to medicines provided, users assisted, and quality of service. Conclusion: The study described the first cycle of an action research project to develop strategies to approach medicines litigation at the municipal level. The application of educational outreach visits for health professionals and group conversations with health system users is a promising approach to improve access to information about pharmaceutical services in Brazil.