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
-
Genéricos
Novedades
- FDA approves generic teriparatide and levetiracetam
- 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
Investigación
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
-
Biosimilares
Novedades
- EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma
- Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars
- EMA recommends approval of ranibizumab, rituximab and trastuzumab biosimilars
- COFEPRIS aprueba los biocomparables bevacizumab Bhava y trastuzumab Mamitra
Investigación
- Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
- Análisis del impacto presupuestario de la introducción de Rixathon en Chile para el linfoma no Hodgkin
- Biosimilars in inflammatory bowel disease: are we ready for multiple switches
- Resultados principales del programa de desarrollo clínico del biosimilar candidato AVT05 golimumab
- MORE EDITORIAL SECTIONS
- Search
Comments (0)
Post your comment