Teva Pharmaceutical Industries announced on 30 September 2010 that the FDA has requested additional information for the Biologic License Application (BLA) for Neutroval (filgrastim), its biosimilar version of Amgen’s Neupogen (granulocyte colony-stimulating factor [G-CSF]). This action by the FDA will effectively delay any launch of the company’s first generic biotech drug in the US.
- 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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