Hope Rugo, MD
Since 2006, the European Medicines Agency has granted marketing authorization for more than 40 biosimilars, and, in less than 4 years, the FDA has approved 17,1,2
yet the knowledge gap in the understanding of biosimilarity poses a unique challenge to the agents’ assimilation into clinical practice and possible impact on access and cost savings, experts say.
. “They’re being used in Europe and the rest of the world. They will come to the United States. My biggest hope for biosimilars is that they’ll improve access to lifesaving therapy.”
Although the FDA has established extensive criteria to evaluate a potential biosimilar, myths about these products persist, Rugo and colleagues wrote in an article in Future Oncology
These include inaccurate perceptions that less clinical and nonclinical evidence is required for their approval, that there are differences in the primary structure between a biosimilar and a reference product, and that biosimilars must have clinical data for each indication to gain approval in that setting.4
Efficacy Data Present for Approvals
In December 2017, MYL-1401O became the first trastuzumab biosimilar to receive FDA approval. Codeveloped by Mylan and Biocon, the biosimilar is indicated in similar settings as trastuzumab: HER2-positive patients with breast cancer or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The approval was based on structural and functional product comparisons, animal data, human pharmacokinetic and pharmacodynamic data, and clinical studies including clinical immunogenicity, the FDA said in announcing the approval.5
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