Biotherapeutic products have revolutionized medicine, changing the way we can treat some chronic diseases, such as autoimmune diseases. The patent expiry and the high costs of reference biotherapeutic products, among other factors, have promoted interest in similar biotherapeutic products (SBPs), also known as biosimilars. The objective of developing an SBP is to manufacture a "highly similar" molecule to a reference biotherapeutic product, by conducting a comparability exercise that can demonstrate similar quality, safety, and efficacy. Regulations like those of the World Health Organization, the European Medicines Agency, and the Food and Drug Administration are international reference standards. Herein, we aim to point out the current status in Latin America on SBPs, focusing on regulatory issues within the context of autoimmune diseases. The regulations of Argentina, Peru, Chile, Guatemala, Panama and Costa Rica follow the World Health Organization guidelines. Other countries, such as Cuba, Mexico, Venezuela, and Brazil have regulations that take into account international standards combined with local features. In Colombia, a draft decree is under revision and the debate is ongoing. Some countries have already approved SBPs. Mexico, Chile, Ecuador, Bolivia, and Peru market SBPs of rituximab, and Colombia markets an SBP of etanercept. The advent of SBPs is definitely beneficial. Safety and efficacy must be ensured following clear and comprehensive regulations.

Biotherapeutic products (BPs) have revolutionized medicine, changing the way we treat several pathologies such as autoimmune diseases and cancer, among others. Herein, we present an overview of similar BPs (SBPs), also called biosimilars, including the manufacturing process and regulatory aspects involved. The objective of developing an SBP is to manufacture a molecule that is highly similar to a reference BP by conducting a comparability exercise (CE) that can demonstrate similar safety and efficacy. This CE consists of quality, as well as nonclinical and clinical evaluation. A case-by-case analysis approach guided by scientific and objective standards must be the foundation for the SBP approval process. The establishment of a balance between a comprehensive CE for SBPs and their reference BPs, and the design of costeffective strategies to provide better access to BPs, should be the key goal for national regulatory authorities.

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Objectives: To assess the cost-effectiveness of Abiraterone Acetate plus Prednisone (A-P) compared with Cabazitaxel plus Prednisone (C-P) in Dominican Republic, in patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) that have failed to chemotherapy with Docetaxel. MethOds: A three-health state cohort simulation Markov Model (progression-free, post-progression and death) was developed based on overall and progression free survival data. The time frame was 10 years. The perspective was that of the Public System of Health of Dominican Republic. The health outcomes of interest were Quality Adjusted Life Years (QALYs) and Life Years (LYs). Efficacy data was taken from clinical trials (COU-AA-301 for A-P and TROPIC for C-P). Utilities for health states and negative utilities for adverse events were estimated based on quality of life endpoints of the COU-AA-301 trial. The base year was 2012. All costs are presented in Dominican currency (Dominican Pesos -RD$). Costs and outcomes were discounted at 5%. Probabilistic sensitivity (PSA) analysis was performed to evaluate uncertainty surrounding the parameters. Results: A-P resulted in 0.79 QALYs and 1.35 LYs, per patient, respectively. C-P resulted in 0.71 QALYs and 1.28 LYs, per patient, respectively. Mean total costs per patient were: RD$ 2.204.289 for A-P and RD$ 2.732.365 for C-P. The results of the probabilistic sensitivity analysis showed that, when compared with C-Z, A-P was found dominant (associated with reduced costs and increased QALYs) in the majority of the iterations. A-P had a 75% probability of being cost effective, independent of the willingness to pay, when compared to C-P. cOnclusiOns: A-P can be considered cost-saving (dominant), when compared with C-P, in patients with Metastatic Castration-Resistant Prostate Cancer that have failed to chemotherapy with Docetaxel, from the perspective of the Public System of Health of Dominican Republic.

Introducción El ictus isquémico puede ser una complicación grave en los pacientes con infección por SARS-CoV-2. Estudiar y caracterizar los diferentes subtipos etiológicos, las características clínicas y el pronóstico funcional podrá resultar útil en la selección de pacientes para un manejo y tratamiento óptimos. Métodos La recogida de variables se hizo de forma retrospectiva en pacientes consecutivos con infección por COVID-19 que desarrollaron un episodio de isquemia cerebral focal (entre el 1 de Marzo 1, 2020, y el 19 de Abril, 2020). Se llevó a cabo en un hospital universitario de tercer nivel en la Comunidad de Madrid. (España). Resultados Durante el período de estudio 1594 pacientes fueron diagnosticados de infección por COVID 19. Identificamos 22 pacientes con ictus isquémico (1.38%), de estos no cumplieron los criterios de inclusión 6. Un total de 16 pacientes con isquemia cerebral focal constituyeron la serie del estudio (15 con ictus isquémico y 1 con accidente isquémico transitorio). En la valoración basal en el National Institutes of Health Stroke Scale (NIHSS) la mediana fue de 9 (Rango Intercuartil RIQ: 16), la edad media fue de 73 años (DE ± 12.8). 12 pacientes fueros varones (75%). El tiempo desde los síntomas de COVID-19 hasta el ictus fue de 13 días. Se encontró oclusión de gran vaso en 12 pacientes (75%). El dímero –D estuvo elevado en el 87.5% y la proteína C reactiva en el 81.2% de los casos. La etiología más frecuente del ictus isquémico fue la aterotrombosis (9 pacientes, 56.3%) con un subtipo predominante que fue el trombo endoluminal sobre placa de ateroma (5 pacientes, 31.2%), 4 de ellos en la arteria carótida interna y uno de ellos en el arco aórtico. La mortalidad en nuestra serie fue del 44% (7 de 16 pacientes). Conclusiones En los pacientes con ictus y COVID-19 la etiología más frecuente fue la aterotrombótica con una elevada frecuencia de trombo endoluminal sobre placa de ateroma (31.2% de los pacientes). Nuestros hallazgos clínicos y de laboratorio apoyan la coagulopatía asociada a COVID-19 como un mecanismo etiopatogénico relevante en el ictus isquémico en este contexto.