FDA approved the first biosimilars listed only one step away

release time:2017年07月19日 source:This site

FDA approved the first biosimilars listed only one step away

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.

Back to News Center