As part of its efforts on harmonizing guidelines around the world the International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has released a reflection paper on the scientific and technical standards for generics.
- 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
- EMA recommend approval for aflibercept, ustekinumab, and pegfilgrastim biosimilars
- FDA approves Hadlima and Otulfi as interchangeable biosimilars
- EC approves three biosimilars, 14 more await final authorization
- FDA approves denosumab biosimilars Stoboclo and Osenvelt
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