The US Food and Drug Administration (FDA) has different requirements for biosimilars depending on whether they are defined as ‘biosimilar’ or ‘interchangeable’ [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
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Biosimilares
Novedades
- New insulin glargine and potential adalimumab interchangeable biosimilars
- Biosimilar advances for Alvotech-Teva and setback for Biocon Biologics
- Advances for Bio-Thera’s secukinumab and mepolizumab copy biologicals
- FDA and EMA file acceptance of Biogen’s tocilizumab biosimilar
Investigación
- EE.UU. frente a Alemania y Suiza: El mercado estadounidense de biosimilares se queda atrás con precios más altos
- Drug survival of adalimumab biosimilars in psoriasis treatment in Spain
- Pegfilgrastim biosimilars in US supportive oncology
- Investigating cell, tissue and gene therapy products and their regulation
General
- Canada’s Ontario introduces biosimilars switching policy
- Hechos clave en la regulación de la aprobación de biosimilares en Brasil
- La provincia canadiense de Saskatchewan introduce una política de switching de biosimilares
- A Canadian gastro-enterologist’s view on advising on biosimilars
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