Actualizaciones regulatorias

Novedades regulatorias de FDA, EMA, TGA y organismos globales

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Actualizaciones regulatorias

21 sept 2026•1 min de lectura

Regulatory Shift Reduces Comparative Clinical Trials in Biosimilar Development

Large-scale comparative clinical efficacy studies are being scaled back, with global regulators emphasizing advanced quality analysis and PK data, according to a KoBIA report.