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A consensus has emerged that approval of biosimilars requires both biological and clinical evidence. The ‘comparability exercise’ requires consideration of a wide range of aspects, including analytical and physico-chemical characterisation by several methods, comparative biological assays, comparative immunogenicity assessment, among others. The use of different host cells for the biosimilar product and the comparator in principle is possible.
- 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
General
- EMA launches European shortages monitoring platform to tackle persistent medicine shortages
- Crecimiento de medicamentos genéricos en Brasil y Venezuela
- Penetración de los medicamentos genéricos en México y Brasil
- FDA releases one-year progress report for the Generic Drug Cluster
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Biosimilares
Novedades
- Canada approves first tocilizumab biosimilar Tyenne
- EMA recommends approval for ustekinumab biosimilar Absimky and Imuldosa
- Canada approves pegfilgrastim biosimilar Armlupeg
- FDA approves fifth ustekinumab biosimilar Imuldosa
Investigación
- Pertuzumab biosimilar HLX11 meets primary endpoint in Phase 3 comparative clinical study
- Perfil del biosimilar Uzpruvo/ AVT04
- 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
General
- Productos biológicos y biosimilares disponibles para la EII en Canadá
- 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
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