Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 22 and 27 May 2020 that the regulatory submissions for its proposed pegfilgrastim biosimilar (MSB11455) had been accepted by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), respectively.
- INICIO
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Genéricos
Novedades
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
- Revlimid (lenalidomide) generics launch across Europe
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Biosimilares
Novedades
- New indication for Cosentyx (secukinumab) biological: hidradenitis suppurativa
- Advances for STADA-Xbrane’s Ximluci in Europe, the UK and the US
- Rinvoq approved to treat Crohn’s disease in Europe
- Advances for Henlius’ trastuzumab and bevacizumab biosimilars in the US
Investigación
- High mannose glycans in biosimilars and their pharmacokinetic impact
- Biosimilars in Southern European Hospital Markets: barriers and determinants of uptake
- Using infliximab economic evaluations in IBD to inform biosimilar access policies
- Biosimilars and other copies of biological products
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