Advances in analytical characterization and increased understanding of drug mechanisms of action have resulted in the ability to raise the quality and safety of biosimilars by introducing critical quality attributes (CQA), which must be preserved during the manufacturing process. However, to realize these benefits, biosimilars manufacturers must develop the means to ensure these CQAs are met. For afucosylated IgG1s that rely on afucosylation content for efficacy, this has been challenging, since precisely matching both afucosylation content and biological activity has proven to be extremely difficult. In a recent paper, Chung and Zhan [1] elaborate on the underlying basis of these difficulties and highlight the work of several groups that has opened a path to directly addressing this problem.
- 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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