Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
Become a Member | Sign in
Home>News>This Article

Sandoz Begins Phase III Studies in the United States for Biosimilar Epoetin Alfa

Published: Friday, October 26, 2012
Last Updated: Friday, October 26, 2012
Bookmark and Share
Company to bring the benefits of a high-quality, safe, effective and affordable epoetin alfa in the US.

Sandoz has started patient enrolment in a late stage clinical trial in the United States for its biosimilar epoetin alfa.

The Phase III study will compare safety and efficacy of Sandoz’s biosimilar epoetin alfa with the US-licensed reference product Amgen/Johnson & Johnson’s Epogen® /Procrit® in anemia associated with chronic kidney disease.

Sandoz’s biosimilar epoetin alfa has been marketed under the brand name Binocrit® in the EU for over 5 years and has generated more than 160,000 patient years in clinical experience.

This new Phase III study will support Sandoz’s goal of registering and launching its biosimilar epoetin alfa in the US.

It is estimated that more than 600,000 patients in the US are treated for anemia with epoetin alfa and similar medicines that regulate the formation of red blood cells.

“This latest study further reinforces Sandoz’s strong commitment to increasing access to high-quality, affordable biopharmaceuticals and further expanding our biosimilars business”, said Ameet Mallik, Head of Biopharmaceuticals and Oncology Injectables.

Mallik continued, “Sandoz is looking forward to bringing the benefits of a high-quality, safe, effective and affordable epoetin alfa to patients, physicians and payors in the US.

Sandoz continues to enroll patients and make progress on its other ongoing Phase II and III trials for rituximab (Roche’s Rituxan®/Mabthera®) and Phase III trials with filgrastim (biosimilar Neupogen® and pegfilgrastim (biosimilar Neulasta®).

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Sandoz Achieves Important Milestones on Phase III Trials for Key Biosimilars Programs
Company is currently preparing to file Filgrastim in the US and pegfilgrastim in the US and EU.
Tuesday, May 06, 2014
Sandoz to Acquire Fougera Pharmaceuticals
Definitive agreement to acquire Fougera Pharmaceuticals for USD 1.525 billion in an all-cash transaction.
Monday, May 14, 2012
Sandoz Initiates Two More Phase III Biosimilar Trials
Latest milestones reinforce long-term global leadership commitment.
Friday, January 27, 2012
Scientific News
Lucentis Effective for Proliferative Diabetic Retinopathy
NIH-funded clinical trial marks first major advance in therapy in 40 years.
Blocking the Transmission Of Malaria Parasites
Vaccine candidate administered for the first time in humans in a phase I clinical trial led by Oxford University’s Jenner Institute, with partners Imaxio and GSK.
First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Treatment for Rare Bleeding Disorder is Effective
Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.
HIV Vaccine Human Trials Begin
Baltimore-based Institute has begun enrolling volunteers for initial phase 1 clinical trials.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Study Removes Cancer Doubt for Multiple Sclerosis Drug
Researchers from Queen Mary University of London are calling on the medical community to reconsider developing a known drug to treat people with relapsing Multiple sclerosis after new evidence shows it does not increase the risk of cancer as previously thought.
Scroll Up
Scroll Down

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos