17 research outputs found
The Portuguese Society of Rheumatology position paper on the use of biosimilars
Biotechnological drugs have become a fundamental resource for the treatment of rheumatic patients. Patent expiry of some of these drugs created the opportunity for biopharmaceutical manufacturers to develop biosimilar drugs intended to be as efficacious as the originator product but with a lower cost to healthcare systems. Due to the complex manufacturing process and highly intricate structure of biologicals, a biosimilar can never be an exact copy of its reference product. Consequently, regulatory authorities issued strict preclinical and clinical guidelines to ensure safety and efficacy equivalence and, in September 2013, the biosimilar of infliximab was the first biosimilar monoclonal antibody to be authorized for use in the European Union. The current document is a position statement of the "Sociedade Portuguesa de Reumatologia" (Portuguese Society of Rheumatology) on the use of biosimilar drugs in rheumatic diseases. Two systematic literature reviews were performed, one concerning clinical trials and the other one concerning international position papers on biosimilars. The results were presented and discussed in a national meeting and a final position document was discussed, written and approved by Portuguese rheumatologists. Briefly, this position statement is contrary to automatic substitution of the originator by the biosimilar, defends either a different INN or the prescription by brand name, supports that switching between biosimilars and the originator molecule should be done after at least 6 months of treatment and based on the attending physician decision and after adequate patient information, recommends the registration of all biosimilar treated patients in Reuma.pt for efficacy, safety and immunogenicity surveillance, following the strategy already ongoing for originators, and opposes to extrapolation of indications approved to the originator to completely different diseases and/or age groups without adequate pre-clinical, safety or efficacy data.info:eu-repo/semantics/publishedVersio
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Sea surface structure of North Brazil Current rings derived from shipboard and moored acoustic Doppler current profiler observations
In the western tropical Atlantic, the North Brazil Current retroflection periodically sheds large anticyclonic rings, which then propagate northwestward. Between 1998 and 2000, the North Brazil Current Rings Experiment sampled a large number of these rings by shipboard and moored acoustic Doppler current profiler. Ten of the sampled rings are analyzed in this study, focusing on their sea surface dynamic properties. The rings exhibit a radial structure consisting of two regimes, an “inner” core region in near solid body rotation and an “outer” ring regime with an approximately exponentially decaying structure. The observations show a sharp change in vorticity at the regime transition and the presence of a strong opposite vorticity shield bounding the inner solid body core. We show that Gaussian models, commonly used to represent the surface expression of these and other rings, are adequate for determining the sea surface height anomaly but tend to poorly estimate other properties such as the maximum swirl velocity. Therefore, we propose a new two‐part model as a better approximation of the rings' radial structure. According to the cyclogeostrophic balance approximation, the sea surface height distribution across the inner ring has a parabolic shape, while the outer ring has an exponential structure similar to the velocity field. Interestingly, many of the observed rings have an intensity very close to the theoretical limit for anticyclones at these latitudes, which is believed to be due to inertial instability