Wednesday, October 24, 2012

Sandoz has initiated Phase 3 trial for Epoetn alfa in the US

Sandoz which is already marketing a biosimilar version of Epoetin alfa in the Europe under the brand name Binocrit for Nephrology and oncology indication has initated Phase 3  trial for its epoetin alfa - HX575  in the US  to support filing.
 About 600,000 patients in the US are treated for anemia.
The open label single arm Phase 3 trial would enrol 360 patietns with chronic kidney disease. The primary endpoint of the trial is Incidence of antibody formation against epoetin. The secondary enpoint includes :
  1. Hemoglobin levels over time and change from baseline 
  2. Weekly epoetin dosage (IU and IU/kg) over time and change from baseline
  3. Incidence of Adverse events

Other Phase 3 trials on biosimilars being done by Sandoz in the US  

Sandoz is also conducting Phase 3 trials on
  1. pegfilgrastim (Neulasta®) - $3billion
  2. filgrastim biosimilar (Neupogen®)- $1billion
  3. Rituximab (Rituxan / Mabthera) - $ 6 billion in annual sales