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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
General
- Crecimiento de medicamentos genéricos en Brasil y Venezuela
- EMA launches European shortages monitoring platform to tackle persistent medicine shortages
- Penetración de los medicamentos genéricos en México y Brasil
- FDA releases one-year progress report for the Generic Drug Cluster
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Biosimilares
Novedades
- FDA approves denosumab biosimilars Stoboclo and Osenvelt
- EMA recommends approval for three denosumab biosimilars: Bomyntra, Conexxence, and Rolcya
- FDA approves bevacizumab biosimilar Jobevne
- EMA recommends nine biosimilars for approval including trastuzumab and denosumab
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