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On 26 June 2014, the European Medicines Agency (EMA) published the new version of its biosimilars quality guideline, which will revise the agency’s 2005 overarching guideline on the quality of similar biological medicinal products. The guideline will come into effect by the end of the year.
- INICIO
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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
- Japan’s drug shortage crisis: challenges and policy solutions
- 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
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Biosimilares
Novedades
- Canada approves pegfilgrastim biosimilar Armlupeg
- FDA approves fifth ustekinumab biosimilar Imuldosa
- EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi
- FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli
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
General
- Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
- La SBR emite consenso sobre intercambiabilidad de productos de referencia y biosimilares
- Un innovador acuerdo de compra directa permite reducir drásticamente los precios de los biosimilares de adalimumab
- Stelara biosimilar available at US$0 for Accredo patients
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