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.
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Generics
News
- 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
- Cancer and diabetes generic treatments receive positive opinion from EMA’s CHMP
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Biosimilars
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- EMA recommends approval of bevacizumab biosimilar Vegzelma
- FDA approves pegfilgrastim and rituximab biosimilars
- Byooviz: first ophthalmology biosimilar launches in US
- Biocon: cancer biosimilar launch in Canada and US$90 million Malaysia deal
Research
- Adalimumab biosimilar MSB11022: PK and tolerability of autoinjector versus pre-filled syringe
- No trends in biosimilars uptake levels in the US, reveals study
- The impact of biosimilar insulins on public spending in Brazil
- Challenges with implementing benefit-sharing programmes for biologicals in Europe
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