Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#biosimilars ×
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.
Actualizaciones regulatorias
2 sept 2026•1 min de lectura
FDA approves five new products in June, spanning cell therapy to biosimilars
The FDA granted approvals for five products in June—including a cell therapy, rare‑disease drug, antibiotic, imaging contrast agent and a biosimilar—signaling trends in advanced biopharma.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
Korean Biotech Firms Rank Second Globally in FDA Biosimilar Approvals
Korean companies have secured 19 of the 87 FDA‑approved biosimilars through June 2026, placing Korea second worldwide after the United States.
Actualizaciones regulatorias
23 ago 2026•1 min de lectura
PMDA Updates Information on Biosimilars
The Pharmaceuticals and Medical Devices Agency (PMDA) has updated its biosimilars information. Details are available on the PMDA website.