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Two novel biosimilars approved in EU and US
The first omalizumab biosimilar in allergic diseases is approved by the EC and US FDA has authorised the fifty third biosimilar in the US.
Sarah yim
Marcus maurer
Amgen bkemv
Drug administration
Institute of allergology
Office of therapeutic biologics
European commission
Professor marcus maurer
Fraunhofer site
Fraunhofer translational medicine
Executive director
Alexion pharmaceutical
Therapeutic biologics
Drug evaluation
Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe
Omlyclo (CT-P39), used to treat allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU), becomes the first omalizumab biosimilar approved in the
Inch on gwangyoksi
South korea
Marcus maurer
European commission
Institute of allergology
European medicines agency
Committee for medicinal products human use
Celltrion inc
European union
Drug administration
Medicinal products
Human use
Professor marcus maurer
Fraunhofer site
Fraunhofer translational medicine
Executive director
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