GP2013
National Institutes of Health
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Background Biosimilars are innovative therapeutic drugs which offer a cheaper alternation for biological which used for…
Comparable clinical efficacy of the rituximab (RTX) biosimilar GP2013 and reference RTX has been established in blinded…
Objectives The aim of this report is to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence as well as similar…
Background GP2013 has been developed as a proposed biosimilar to originator rituximab (RTX), by Sandoz, a Novartis Company. The…
Abstract Biosimilar development involves a target-directed iterative process to ensure a similar product to the originator. Here…
3075 Background: Development of a biosimilar involves extensive characterization of the originator product and a target-directed…
Regulatory approval for a biosimilar product is provided on the basis of its comparability to an originator product. A thorough…