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...
More >Canada poised to remove requirement for Phase III trials for biosimilars
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Posted 22/07/2025
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FORO LATINOAMERICANO DE ESTA SEMANA
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...
Biosimilars in low- and middle-income countries
Posted 05/03/2025
Biosimilars offer a viable route to treatment for those with non-communicable diseases...
Comparative efficacy studies: where are we now?
Posted 08/01/2025
In an article published in GaBI Journal titled ‘Comparative efficac...
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...
Biosimilars in low- and middle-income countries
Posted 05/03/2025
Biosimilars offer a viable route to treatment for those with non-communicable diseases...
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
FDA issues final guidance on liposome drug products
Posted 27/04/2018
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On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...
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