The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
- 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
- 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
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Biosimilares
Novedades
- FDA approves filgrastim biosimilar Nypozi
- FDA approves third aflibercept biosimilar Ahzantive
- Richmond lanzará los biológicos similares bevacizumab Yriviak y adalimumab Armixa
- China approves Simcare’s cetuximab beta Enlituo
Investigación
- 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
- Eficacia y seguridad del P043 propuesto (Zerafil) frente al omalizumab de referencia en el asma alérgica
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