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Regulatory approvals for new biological drugs in the US have nearly doubled in the last decade compared with the 1990s, according to the May/June 2011 issue of the Tufts Center for the Study of Drug Development (CSDD) Impact Report. However, the author of the report, Research Assistant Professor Janice Reichert, said there are still ‘substantial challenges’ to be faced by biologicals manufacturers if they wish to ‘maintain that pace’.
- 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
- 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
- FDA approves aflibercept biosimilars Enzeevu and Pavblu
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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