Measures of #biosimilarity in monoclonal antibodies in oncology: case of bevacizumab #mAbs #biosimilars #biosimilar
Challenges remain in establishing biosimilarity of anticancer agents.
Preclinical studies can be sensitive but can lack clinical relevance.
It is not realistic to establish noninferiority of biosimilar bevacizumab using accepted clinical outcomes.
Novel clinical endpoints may include adverse reactions or unauthorized indications.
The authorization of biosimilars in oncology at realistic costs requires novel approaches.
Via Krishan Maggon