RESUMEN
We report the available evidence demonstrating the biosimilarity of ABP 501 (AMGEVITA®, adalimumab-atto) to its reference product (RP) (Humira®, adalimumab), and the rationale for the extrapolation of the results obtained with the RP in inflammatory bowel disease (IBD) to ABP 501. Based on its preclinical and clinical data, ABP 501 has been authorized for use in Europe in all the indications approved for the RP, including Crohn's disease and ulcerative colitis.
Asunto(s)
Biosimilares Farmacéuticos , Colitis Ulcerosa , Enfermedad de Crohn , Enfermedades Inflamatorias del Intestino , Adalimumab/uso terapéutico , Biosimilares Farmacéuticos/uso terapéutico , Enfermedad de Crohn/tratamiento farmacológico , Humanos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológicoRESUMEN
Detergent-solubilized bovine rhodopsin produces mixed detergent/lipid/protein micelles. The effect of dodecyl maltoside detergent on the thermal stability of dark-state rhodopsin, and upon formation of the different intermediates after rhodopsin photobleaching (metarhodopsin II and metarhodopsin III), and upon transducin activation has been studied. No significant effect is observed for the thermal stability of dark-state rhodopsin in the range of detergent concentrations studied, but a decrease in the stability of metarhodopsin II and an increase in metarhodopsin III formation is observed with decreasing detergent concentrations. The transducin activation process is also affected by the presence of detergent indicating that this process is dependent on the lipid micro-environment and membrane fluidity, and this stresses the importance of the native lipid environment in rhodopsin normal function.