EMA announced on 28 September 2012 that it has adapted its guidance in order to make it easier for new biosimilar products to be approved in the EU. The changes in policy mean that EMA will accept clinical data from biosimilar medicines approved outside the European Economic Area (EEA).
- 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
Investigación
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
- Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
- Trajectories of prices in generic drug markets
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Biosimilares
Novedades
- EMA recommends approval of trastuzumab biosimilar Herwenda
- FDA approves first natalizumab biosimilar Tyruko for MS
- EMA recommends approval of first natalizumab biosimilar Tyruko for MS
- EMA recommends approval of first aflibercept and tocilizumab biosimilars
Investigación
- Barreras de la Enfermedad Inflamatoria Intestinal (EII): un análisis de América Latina
- Biosimilares oftalmológicos en Canadá: la perspectiva de un prescriptor
- Respuesta a Opinión sobre: Cuatro pasos para racionalizar el desarrollo de biosimilares
- Cuatro pasos para racionalizar el desarrollo de biosimilares
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