In the US, manufacturers seeking approval to market a generic drug product must submit data demonstrating that the generic formulation provides the same rate and extent of absorption as (i.e., is bioequivalent to) the innovator drug product. Thus, most orally administered generic drug products in the US are approved based on results of one or more clinical bioequivalence studies.
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Generics
News
- 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
- Cancer and diabetes generic treatments receive positive opinion from EMA’s CHMP
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Biosimilars
News
- New adalimumab biosimilars prepare to launch in Canada, US and Europe
- FDA approves Amneal’s bevacizumab biosimilar
- Europe: positive opinion for Inpremzia and Truvelog Mix 30 and Stimufend authorized
- FDA approves Kashiv Biosciences’ filgrastim biosimilar
Research
- Totality of evidence supporting approval of Avsola in the treatment of IBD
- Innovent and Eli Lilly announce final results for sintilimab plus biosimilar bevacizumab injection
- Survey results of biosimilars use among Spanish physicians and pharmacists
- Amgen announces positive phase III results for ustekinumab biosimilar
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