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Two novel biosimilars approved in EU and US
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
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paroxysmal nocturnal hemoglobinuria (PNH)
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European Commission approves haematology biosimilar
A marketing authorisation for a biosimilar to eculizumab has been granted by the European Commission for paroxysmal nocturnal haemoglobinuria.
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Novartis releases data for potentially “practice-changing” PNH medicine
Iptacopan achieved "improvement of anaemia never seen before with anti-C5s” in paroxysmal nocturnal haemoglobinuria, showed Novartis data presented at 2023 EBMT.
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Eculizumab biosimilar gets positive CHMP opinion
Samsung Bioepis’ first haematology biosimilar, which references Soliris (eculizumab), has been recommended for approval by the CHMP.
