Abbott Laboratories (Abbott) submitted a 30-page citizen petition to FDA on 2 April 2012 asking the agency to reject any biosimilar for its rheumatoid arthritis drug Humira (adalimumab). Abbott says that FDA would be forced to use trade secrets included in Humira’s Biologics License Application (BLA) to approve biosimilars. Abbott is therefore requesting that FDA refuses to review any biosimilar biological whose BLA was submitted before the Biologic Price Competition and Innovation (BPCI) Act of 2009 came into effect on 23 March 2010.
- 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
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Biosimilares
Novedades
- Canada approves pegfilgrastim biosimilar Armlupeg
- FDA approves fifth ustekinumab biosimilar Imuldosa
- EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi
- FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli
Investigación
- Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
- Análisis del impacto presupuestario de la introducción de Rixathon en Chile para el linfoma no Hodgkin
- Biosimilars in inflammatory bowel disease: are we ready for multiple switches
- Resultados principales del programa de desarrollo clínico del biosimilar candidato AVT05 golimumab
General
- Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
- La SBR emite consenso sobre intercambiabilidad de productos de referencia y biosimilares
- Un innovador acuerdo de compra directa permite reducir drásticamente los precios de los biosimilares de adalimumab
- Stelara biosimilar available at US$0 for Accredo patients
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