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paroxysmal nocturnal hemoglobinuria (PNH)

Two novel biosimilars approved in EU and US

29 May 2024 | By Catherine Eckford (European Pharmaceutical Review)

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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European Commission approves haematology biosimilar

30 May 2023 | By Catherine Eckford (European Pharmaceutical Review)

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

26 April 2023 | By Catherine Eckford (European Pharmaceutical Review)

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

6 April 2023 | By Catherine Eckford (European Pharmaceutical Review)

Samsung Bioepis’ first haematology biosimilar, which references Soliris (eculizumab), has been recommended for approval by the CHMP.

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Recommended

paroxysmal nocturnal hemoglobinuria (PNH)

Two novel biosimilars approved in EU and US

European Commission approves haematology biosimilar

Novartis releases data for potentially “practice-changing” PNH medicine

Eculizumab biosimilar gets positive CHMP opinion