FDA approved the first biosimilars listed only one step away
release time:2017年07月19日 source:This site
The US FDA Drug Evaluation Center (CDER) recently held a meeting of the Expert Consultative Committee on Cancer Drugs (ODAC) to review the biosynthetic drug EP2006 (European trade name: Zarzio) of the Neumogen, a subsidiary of Sandoz, Licensing Application (BLA). After hearing the report of the mountain company, the FDA reviewers' comments and public hearings, the FDA expert group unanimously approved the approval of the Citadel's EP2006 (US name: Zarxio) at 14: 0, Only one step away from the FDA's approval of the first biosimilant market.
The main agenda of the ODAC meeting included the interpretation of the biosimilars 351 (k) review rules by the Drug Evaluation Center (CDER), the slides presentation of the mountain data for the EP2006, and the FDA reviewers from CMC, Bioactivity, Immunogenicity, Pathology and toxicology, clinical trials and other aspects of the EP2006 declaration of materials, expert group questions, as well as patients, doctors, insurance companies, generic drug manufacturers, including public hearings. I believe that the panel of experts today to ask the material is not sharp, mainly for EP2006 and Neupogen compared to the plasma concentration is slightly lower (about 10% lower), although the usual 20% of the range, but whether the results will be converted To the clinical doubt.
The mountain company demonstrated a number of batches of EP2006, Neupogen, and European-listed Zarzio's head-to-head comparison results, suggesting that although EP2006 and Neupogen were slightly lower in blood concentrations compared to the control group, the recovery of neutrophils And the level of biomarker CD34 did not show a difference, and the biomechanical treatment group and the control group compared to the incidence of adverse events is no different. As a result, the FDA team of experts eventually agreed to EP2006 and Annan Neupogen with a 14-0 vote, suggesting that the FDA should approve Zarxio listing. Because FDA reviewers and panelists unanimously recommend approval of the EP2006 Biologics License Application (BLA), it is estimated that EP2006 approval from the FDA is a foregone conclusion.
