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Results for 'ERBB2'

Evaluating External Validity of Oncology Biosimilar Safety Studies
OVN Avatar Gregory S. Calip, PharmD, MPH, PhD, Ivy P. Altomare, MD, Jenny S. Guadamuz, MSPH, PhD
Evaluating External Validity of Oncology Biosimilar Safety Studies

biologics, external validity, FDA, biosimilars, trastuzumab

Biologics are the fastest growing medication class in the US, significantly contributing to healthcare costs. The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway to make biological products more accessible. A phase 3 randomized trial of SB3, a trast…

Apr 6th • 2 mins read

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