EU steps closer to the ‘tailored approach’ for biosimilars development

Reports/ | Posted 21/11/2025 comments 0
05 AA011027

In September 2025, the European Medicines Agency’s (EMA) Biosimilar Medicinal Products Working Party (BMWP) held a ‘Workshop on a tailored clinical approach in biosimilar development’ to discu...

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

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Biosimilars in low- and middle-income countries
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In an article published in GaBI Journal titled ‘Comparative efficac...

Home/Non‐Biological Complex Drugs
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On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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