A paper published in Drugs, explores the evolution in biosimilars regulatory thinking which is now moving away from the default requirement for clinical efficacy studies (CES) for approval [1]...
More >Biosimilar clinical efficacy studies: are they still necessary?
Biosimilars/Research
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Posted 27/05/2025
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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
0
On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...
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