Three years after first issuing draft guidance on biosimilars, the US Food and Drug Administration (FDA) has finally issued three final guidelines for biosimilar applications in the US. The guidances, however, fail to address the issue of interchangeability with reference biologicals, which the agency says it will address in another document.
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Generics
News
- 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
Research
- 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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Biosimilars
News
- 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
Research
- 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
- Malaysian hospital pharmacists’ perspective on and role in promoting biosimilars use
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