The US Food and Drug Administration (FDA) awarded Eli Lilly’s Rezvoglar, an insulin glargine biosimilar, the interchangeable designation in late 2022. This means that in the US, Rezvoglar can now be substituted at the pharmacy level for the originator, Sanofi’s Lantus, without a doctor’s prescription, provided state pharmacy law permits the switch. In addition, a study revealed that Pfizer’s adalimumab biosimilar may also soon achieve this status.
- 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?
General
- IFPMA publica su posición sobre la sustitución de biosimilares mediada por farmacias
- The ustekinumab shift: biosimilars displace Stelara’s market leadership
- La ley brasileña establece el 16 de diciembre como Día Nacional del Biosimilar
- Biosimilars approved in the US
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