Companies seeking to launch a generic drug are required to submit a dossier to authorities, which does not contain the results of extensive preclinical and clinical testing demonstrating safety and efficacy in the target population, as is the case with novel drugs, but only limited data and evidence demonstrating the fundamental premise that the generic is bioequivalent to its brand-name counterpart.
- 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
- EMA launches European shortages monitoring platform to tackle persistent medicine shortages
- Crecimiento de medicamentos genéricos en Brasil y Venezuela
- 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
- Canada approves pegfilgrastim biosimilar Pexegra
- Insulin aspart and denosumab biosimilars approved in US
- FDA approves tocilizumab biosimilar Avtozma
- January 2025 biosimilar approvals in Europe
Investigación
- Optimización de costes con biosimilares: El caso de Brasil
- Biosimilares en países de ingresos bajos y medios
- Resultados positivos del criterio principal de seguridad y eficacia de AVT05 (biosimilar propuesto de golimumab)
- ¿Están en riesgo los biosimilares intercambiables?
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