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 2,600+ scientific posters on ePosters
  • More than 3,800+ 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
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.
Antibody Treatment Efficacious in Psoriasis
An experimental, biologic treatment, brodalumab, achieved 100 percent reduction in psoriasis symptoms in twice as many patients as a second, commonly used treatment, according to the results of a multicenter clinical trial led by Mount Sinai researchers.
Scientists Test New Gene Therapy for Vision Loss from a Mitochondrial Disease
NIH-funded study shows success in targeting mitochondrial DNA in mice.
HIV Patients Should Be Included in Early Clinical Trials of Anti-TB Drugs
Tuberculosis is the number one cause of death in HIV-infected patients in Africa and a leading cause of death in this population worldwide.
Multi-Gene Test Enables Some Breast Cancer Patients to Safely Avoid Chemotherapy
A major study is providing the best evidence to date that a 21-gene test done on the tumor can identify breast cancer patients who can safely avoid chemotherapy.
Low Dose Beta-Blockers As Effective As High Dose After a Heart Attack?
Heart attack patients live as long – or even longer – on one-quarter the suggested dose.
Antidepressants Plus Blood-Thinners Slow Down Brain Cancer
EPFL scientists have found that combining antidepressants with anticoagulants slows down brain tumors (gliomas) in mice.
Old Drug Performs New Tricks
Cambridge-led research reveals the powers of a "wonder drug" that has lain under the noses of doctors for 50 years.
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
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos