News
FDA approves Hadlima and Otulfi as interchangeable biosimilars
<p>In May 2025, the US Food and Drug Administration (FDA) has designated Samsung Bioepis and Organon’s Hadlima (adalimumab-bwwd) autoinjectors and prefilled syringes as the ...
Alvotech partnerships and acquisition: Dr Reddy’s, Advanz, Xbrane
<p>Alvotech and Dr Reddy’s collaborate to develop a Keytruda biosimilar. Alvotech completes its Xbrane R & D acquisition and expands its Advanz Pharma partnership, accelerating ...
DIGEMID’s 45-day auto-approvals trigger safety warning
<p>Peru’s new regulation allows automatic drug approval if DIGEMID does not respond within 45 days, raising concerns about compromised safety controls. Critics warn it may permit substandard ...
EC approves three biosimilars, 14 more await final authorization
<p>The European Commission (EC) granted marketing authorization for three biosimilars: Amgen’s Pavblu, CuraTeQ Biologics’s Dyrupeg, and Celltrion’s Qoyvolma, between March and June ...
European position paper on AI in medicinal product lifecycle
<p>At the end of 2024, the European Medicine’s agency (EMA) published a reflection paper on ‘The use of Artificial Intelligence (AI) in the medicinal product lifecycle,’ [1]. This was based on ...
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