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En junio de 2024, se publicó en Brasil, en el Diario Oficial de la Unión (DOU) [1], la Resolución RDC nº 875, que modifica la normativa vigente en materia de registro de productos biológicos (RDC 55/2010).
- 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
- EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi
- FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli
- FDA approves second strength of trastuzumab biosimilar Hercessi
- EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz
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
- 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
- Los diez biosimilares más vendidos en Brasil en 2023
- International biosimilars players expanding their presence in China
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