RESUMO
The development of a biosimilar is based on comparative structural, physicochemical, functional and clinical assessments. The sum of these analyses encompasses the 'totality of evidence', which demonstrates no clinically meaningful differences between the biosimilar and the reference product (RP). Once biosimilarity has been established, provided there is suitable scientific justification, clinical data may be extrapolated to other indications of the RP. AVT02 has been developed as a biosimilar to high-concentration, low-volume Humira (adalimumab), an anti-tumour necrosis factor-alpha monoclonal antibody approved for various chronic inflammatory indications. The totality of evidence for AVT02 is described, supporting its approval as an adalimumab biosimilar for all approved indications globally. Analytical similarity assessments using mass spectrometry methods demonstrated identical amino acid sequences for AVT02 and the RP, with high similarity in terms of primary structure, post-translational modifications and higher-order structural attributes. The mechanism of action was assessed by various cell-based potency assays and binding assays, and the results demonstrated that AVT02 is highly similar to the RP. No clinically meaningful differences in terms of purity, potency and safety were observed, and minor differences in a few physiochemical attributes did not impact the in vitro biologic activity and were not considered clinically relevant. Clinical similarity was demonstrated by comparing the pharmacokinetic, efficacy, safety and immunogenicity profiles of AVT02 with those of the RP. Clinical studies supported similar pharmacokinetic and comparable immunogenicity profiles between AVT02 and the RP in healthy participants and participants with moderate-to-severe chronic plaque psoriasis, with no new safety signals detected. The totality of evidence described demonstrates the biosimilarity of AVT02 to the RP, thereby fulfilling the scientific and regulatory requirements for AVT02 as a high-concentration biosimilar for the treatment of chronic plaque psoriasis and all approved indications of the RP.
Demonstrating the high similarity between the biosimilar AVT02 (adalimumab) and Humira, supporting AVT02 to be used to treat all conditions currently treated with Humira Biosimilars are drugs that have similar quality, effectiveness, and safety profiles to an already approved biological drug, which is referred to as the 'reference product (RP)'. Although biosimilars have identical amino acids (the building blocks that make up proteins) to the RPs, they are manufactured in living cells which leads to a small amount of natural variability. Therefore, extensive testing is required to confirm that a biosimilar is highly similar to the RP. The 'totality of evidence' is a set of tests to demonstrate that there are no meaningful differences between the biosimilar and the RP, in other words, that there is 'biosimilarity' between the biosimilar and RP. Once biosimilarity has been proven, the biosimilar may be used to treat all the diseases currently treated with the RP, without the need for separate clinical trials in each disease. AVT02 has been developed as a biosimilar to Humira, an antibody approved for various chronic inflammatory diseases such as chronic plaque psoriasis (PsO). A step-by-step approach was used to show biosimilarity of AVT02 to Humira. This included clinical studies (in healthy individuals and participants with moderate to severe chronic PsO) and non-clinical studies (comparisons of the chemistry of the drugs and how they work in the body). Clinical studies in healthy individuals and participants with PsO showed that AVT02 and Humira were taken up and degraded by the body in a similar way, peoples' immune response to the two drugs were similar, and both drugs had similar side effects. No clinically meaningful differences in the purity, effectiveness, and safety of AVT02 compared with Humira were seen. The evidence demonstrates the biosimilarity of AVT02 to Humira and supports the use of AVT02 to treat all conditions which are currently treated with Humira.
RESUMO
Background: More than 120 million women worldwide want to avoid pregnancy, but most are not using contraception. This could be because they may not have received clear instructions on how to use the method properly, may not have obtained the most appropriate method for their needs, or may not have been aware of the side effects. Objective: To compare the acceptance of family planning methods (FPM) in women attended for childbirth, caesarean section, and curettage. Material and methods: Cross-sectional, analytical, prolective study. Women between 18 and 40 years of age in the immediate puerperium attended at a third level hospital were included. A survey which included 5 items with multiple choice answers and 7 with open answers was applied. General data were gathered, included the acceptance or not of some planning method, and the reason for its use or rejection. In addition, it was identified which methods they knew, if they received counseling and the perspective of effectiveness. Results: A total of 648 women were included; 216 women in each group. It was found that there is a higher percentage of acceptance of FPM in women attended by cesarean section, compared to those attended by delivery and curettage (p = 0.0158). Conclusions: Women attended by cesarean section are more willing to approve FPM, compared to those attended by delivery and curettage. Those patients who receive counseling are the most informed and the ones who approve FPM. Nurses and family physicians are the health workers who offer more counseling.
Introducción: más de 120 millones de mujeres en el mundo quieren evitar el embarazo, pero la mayoría no están empleado algún método anticonceptivo. Esto puede deberse a que no hayan recibido instrucciones claras acerca de cómo utilizar el método de manera adecuada, no hayan conseguido el anticonceptivo más apropiado a sus necesidades o no conocieran los efectos secundarios. Objetivo: comparar la aceptación de los métodos de planificación familiar (MPF) de mujeres atendidas de parto, cesárea y legrado. Material y métodos: estudio transversal, analítico, prolectivo. Se incluyeron mujeres entre 18 y 40 años que estaban en puerperio inmediato y que fueron atendidas en un hospital de tercer nivel. Se aplicó una encuesta que incluía 5 ítems con respuesta de opción múltiple y 7 con respuestas abiertas. Se tomaron datos generales, la aceptación o no de algún método de planificación, el motivo de su uso o rechazo. Además, se identificaron cuáles métodos conocían, si recibieron consejería y la perspectiva de la efectividad. Resultados: se incluyeron 648 mujeres, 216 por cada grupo. Se encontró que hay un mayor porcentaje de aceptación de los MPF en mujeres atendidas por cesárea, en comparación con aquellas atendidas por parto y legrado (p = 0.0158). Conclusiones: las mujeres atendidas por cesárea aceptan más los MPF, en comparación con aquellas atendidas por parto y legrado. Las pacientes que reciben consejería son las más informadas y las que aceptan más los MPF. Enfermería y médicos familiares son el personal de salud que más otorga consejería.
