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FDA aprueba sexto biosimilar de ustekinumab: Yesintek
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La FDA ha dado su aprobación a Yesintek (ustekinumab-kfce), el sexto biosimilar de Stelara (ustekinumab), para tratar la enfermedad inflamatoria intestinal, la psoriasis en placas y la artritis psoriásica.
Según los Institutos Nacionales de Salud (NHC, siglas en inglés), la prevalencia de la artritis psoriásica (PsA) en EE. UU. varía de 6 por cada 100,000 a 25 por cada 100,000. Además, la enfermedad inflamatoria intestinal (IBD) afecta a entre 2.4 millones y 3.1 millones de personas en EE. UU., con una prevalencia creciente y costos de atención médica que ascendieron a $8.5 mil millones anuales en 2018, según los Centros para el Control y la Prevención de Enfermedades (CDC).
Desarrollado por Biocon Biologics, con sede en Karnataka, India, este biosimilar tiene previsto su lanzamiento en la segunda mitad de 2025, junto a Otulfi (ustekinumab-aauz), Selarsdi (ustekinumab-aekn), Imuldosa (ustekinumab-srlf) y Pyzchiva (ustekinumab-ttwe). Por otro lado, Wezlana (ustekinumab-auub), el primer biosimilar aprobado de Stelara, será lanzado en enero de 2025, tras un acuerdo de conciliación con Johnson and Johnson (J&J).
El último biosimilar en ser aprobado tiene previsto su lanzamiento en los Estados Unidos antes del 22 de febrero, según un acuerdo alcanzado entre Biocon Biologics y Janssen, la división de Johnson & Johnson (J&J). Esta aprobación se suma a una serie de lanzamientos recientes, entre ellos Imuldosa, que fue aprobado en octubre de 2024; Otulfi en septiembre de 2024; Pyzchiva en julio de 2024; y Wezlana, aprobado en octubre de 2023.
D clave que permitieron la aprobación de Yesintek, biosimilar de ustekinumab:
Biocon Biologics compartió los datos de los ensayos clínicos sobre Yesintek en el Congreso 2024 de la Academia Europea de Dermatología y Venereología (EADV). Los datos correspondieron a un estudio multicéntrico, aleatorizado, doble ciego de fase 3 que evaluó el biosimilar frente al biológico de referencia en 384 pacientes adultos con psoriasis crónica en placas de moderada a severa.
Durante 28 semanas, el principal punto de eficacia, el cambio porcentual desde el valor base en el Índice de Área y Gravedad de la Psoriasis, mostró equivalencia entre Yesintek y Stelara. El estudio también confirmó perfiles comparables en cuanto a seguridad, inmunogenicidad y farmacocinética.
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