As drug manufacturers await guidance on a biosimilar approval pathway in the US, the debate goes on as to how high the bar will be set for the FDA to designate a biosimilar as interchangeable. In one critical area of the law that outlines biosimilar regulations, Congress outlines the difference between biosimilarity and interchangeability with respect to biosimilars and innovative biologicals, but the FDA has yet to define the difference.
- 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
- Evaluation of pharmaceutical equivalency of manufactured generic drugs in UAE
- New insights into the amount of R & D for new uses of generic drugs
- Pricing and reimbursement of medicines in Canada
- Medicines pricing conditions in Italy and Brazil: comparison of regulations
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Biosimilares
Novedades
- EMA recommends approval of eculizumab biosimilar Bekemv
- China approves tocilizumab copy biological BAT1806
- FDA accepts application for denosumab biosimilar GP2411
- EMA accepts application for ustekinumab biosimilar AVT04
Investigación
- Low biosimilar uptake in regions of low social and political trust
- A global overview of manufacturers of follow-on biologicals
- Study supports increased development of insulin biosimilars
- Perspectiva y papel de los farmacéuticos hospitalarios de Malasia en la promoción del uso de biosimilares
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