Dr Kellie Taylor, Associate Director of the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology at the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), gave an update on the agency’s naming policies for biologicals/biosimilars at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on 24−25 October 2017 in Bethesda, Maryland, USA [1].
- 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
- Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars
- EMA recommends approval of ranibizumab, rituximab and trastuzumab biosimilars
- COFEPRIS aprueba los biocomparables bevacizumab Bhava y trastuzumab Mamitra
- EMA recommends approval of four ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi, Steqeyma
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
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