Canada poised to remove requirement for Phase III trials for biosimilars

Guidelines/ | Posted 22/07/2025 comments 0
Clinical Trials V13F14

On 10 June 2025, Health Canada issued ‘Guidance document: Information and submission requirements for biosimilar biologic drugs (2025 – Revised draft)’ [1]. Key to this new draft is the p...

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FORO LATINOAMERICANO DE ESTA SEMANA
Optional Mandatory V19C01
Advances in EMA plans to streamline biosimilar assessment
Posted 07/04/2025

On 1 April 2025, the European Medicines Agency (EMA) published a ‘draft reflection pape...

Turkey 2016 COVER V16E31DG
Biosimilars in low- and middle-income countries
Posted 05/03/2025

Biosimilars offer a viable route to treatment for those with non-communicable diseases...

Clinical trial PainSA V21F04
Comparative efficacy studies: where are we now?
Posted 08/01/2025

In an article published in GaBI Journal titled ‘Comparative efficac...

Home/Non‐Biological Complex Drugs
Liposome V15L11

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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