Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

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

Join For Free

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 2,900+ scientific posters on ePosters
  • More Than 4,200+ 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 TechnologyNetworks.com 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

FDA Accepts Sandoz Regulatory Submission For Etanercept
Etanercept is an anti-TNF medicine used to treat a range of immunological diseases including rheumatoid arthritis and psoriasis.
Monday, October 05, 2015
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 Receives Japanese Approval for Biosimilar Filgrastim
Approval paves the way for this oncology medicine to be made available to oncology patients in Japan.
Monday, March 24, 2014
Sandoz Expands Kundl Site Sterile Production
Production expansion will create 30 new jobs at the site and reinforces the Kundl site’s position as a leading producer of sterile injectables.
Tuesday, March 12, 2013
New Study Shows Biosimilars can Save Healthcare Systems of Eight EU Countries up to EUR 33 Billion by 2020
Faster access and interchangeability between reference drugs and biosimilars seen as critical to realizing savings.
Friday, May 25, 2012
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 to Present at FDA Hearing on Biosimilars
Sandoz supports FDA in its efforts to improve access to safe, efficacious, affordable biologics and agrees with the flexible, step-by-step approach outlined in draft guidances.
Monday, May 14, 2012
Sandoz Initiates Two More Phase III Biosimilar Trials
Latest milestones reinforce long-term global leadership commitment.
Friday, January 27, 2012
NICE Issues First Biosimilar Recommendation
Latest NICE cost-benefit guidance includes Sandoz’s Omnitrope® as one of seven recommended somatropin products to treat growth failure in children.
Tuesday, December 13, 2011
Scientific News
Microdroplet Reactors Mimic Living Systems
Researchers use microdroplets to study non-equilibrium reactions like those in living organisms.
NIH Researchers Identify Striking Genomic Signature for Cancer
Institute has identified striking signature shared by five types of cancer.
CRI Develops Innovative Approach for Identifying Lung Cancer
Institute has developed innovative approach for identifying processes that fuel tumor growth in lung cancer patients.
Envigo Rat Models Proven to be Susceptible to Intra-Vaginal HSV-2 Infection and Protectable
Scientific findings establish the effectiveness of new approach to investigate the protective effects of vaccine candidates and anti-viral microbodies and to study asymptomatic primary genital HSV-2 infection.
What do Banana Peels and Human Skin Have in Common?
Human skin and banana peels have something in common: they produce the same enzyme when attacked. By studying fruit, researchers have come up with an accurate method for diagnosing the stages of this form of skin cancer.
The Spice of Life
Scientists discover important genetic source of human diversity.
Cytoskeleton Crew
Findings confirm sugar's role in helping cancers survive by changing cellular architecture.
The Power of Three
Overlooked portion of cell “death receptor” critical in some cancers, autoimmune diseases.
Drug that Activates Innate Immune System Identified
Researchers from the institute have identified a drug, which is straightforward to synthesize and to couple to antigens that induce an immune response and may prove useful in the generation of vaccines.
Removing Race from Human Genetic Research
A group of scientists are urging their colleagues to take a step forward and stop using racial categories when researching and studying human genetics.
Scroll Up
Scroll Down
Skyscraper Banner

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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!