During the DIA Biosimilars Conference 2021 a presentation entitled ‘An update on the FDA biosimilar program: progress and directions, 2021’ was given by Dr Peter Stein, Director of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA). In this presentation, Dr Stein outlined the role that pharmacodynamic (PD) biomarkers have with respect to biosimilars [1].
- INICIO
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Genéricos
Novedades
- 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
- Revlimid (lenalidomide) generics launch across Europe
Investigación
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
- Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
- Trajectories of prices in generic drug markets
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Biosimilares
Novedades
- FDA approves first natalizumab biosimilar Tyruko for MS
- EMA recommends approval of first natalizumab biosimilar Tyruko for MS
- EMA recommends approval of first aflibercept and tocilizumab biosimilars
- Alvotech: rejection AVT02 in the US and new partnerships with Prolifarma and Advanz Pharma
Investigación
- Biosimilares oftalmológicos en Canadá: la perspectiva de un prescriptor
- Respuesta a Opinión sobre: Cuatro pasos para racionalizar el desarrollo de biosimilares
- Cuatro pasos para racionalizar el desarrollo de biosimilares
- Biosimilares: actitudes y percepciones de los prescriptores estadounidenses
General
- Coherus retracts AbbVie restraining order in Humira biosimilar dispute
- Proposal to widen access to trastuzumab in New Zealand
- Actualización de la declaración de posición de GADECCU sobre los biosimilares
- GADECCU presenta un nuevo posicionamiento sobre biosimilares
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