A legal framework for approving biosimilars in the US was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). As part of the Food and Drug Administration’s (FDA) implementation of the BPCI Act, the agency published draft guidance on biosimilar interchangeability in January 2017 [2].
- INICIO
-
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
-
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?
- MORE EDITORIAL SECTIONS
- Search
Post your comment