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

Sandoz Achieves Important Milestones on Phase III Trials for Key Biosimilars Programs

Published: Tuesday, May 06, 2014
Last Updated: Tuesday, May 06, 2014
Bookmark and Share
Company is currently preparing to file Filgrastim in the US and pegfilgrastim in the US and EU.

Sandoz continues to advance its industry-leading biosimilars pipeline that currently has six molecules in the Phase III clinical trial/filing prep phase.

As part of the Novartis Q1 announcements, Sandoz has announced the following biosimilar development milestones:

• Sandoz completed the patient enrollment for its Phase III trial with biosimilar etanercept (Amgen's Enbrel®). The global clinical trial seeks to confirm biosimilarity with regard to safety, efficacy and immunogenicity of the Sandoz product versus Enbrel in patients with moderate to severe chronic plaque-type psoriasis.

• Sandoz also completed a Phase III trial for the US registration of biosimilar filgrastim (Amgen's Neupogen®) and two global Phase III trials for global registration of biosimilar pegfilgrastim (Amgen's Neulasta®). The trials aimed to confirm biosimilarity of the Sandoz biosimilars versus Neupogen® and Neulasta® in breast cancer patients eligible for myelosuppresive chemotherapy treatment.

Sandoz also continues to make strong progress on its other biosimilar clinical development programs which includes biosimilar versions of rituximab (Roche's Rituxan®/MabThera®) and adalimumab (AbbVie's Humira®).


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 3,500+ scientific posters on ePosters
  • More Than 5,000+ 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 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

Study Shows Sandoz Biosimilar Equivalent to Originator Drug
New data shows Sandoz biosimilar candidate has equivalent efficacy to originator etanercept following comparison in psoriasis.
Tuesday, July 12, 2016
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 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
Sandoz Begins Phase III Studies in the United States for Biosimilar Epoetin Alfa
Company to bring the benefits of a high-quality, safe, effective and affordable epoetin alfa in the US.
Friday, October 26, 2012
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
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
One Step Closer to Precision Medicine for Chronic Lung Disease Sufferers
A study led by University of North Carolina at Chapel Hill, and National Jewish Health, has provided evidence of links between SNPs and known COPD blood protein biomarkers.
ReadCoor Launched to Commercialize 3D Sequencing Tech
ReadCoor will leverage the Wyss Institute’s method for simultaneously sequencing and mapping RNAs within cells and tissues to advance development of diagnostics.
Ancient Eggshell Protein Breaks Through DNA Time Barrier
Fossil proteins from a 3.8million year-old eggshell have been identifed, suggests proteins could give insight into evolutionary tree.
Monkeys Protected by Zika DNA Vaccine
Experimental Zika virus DNA vaccines successfully protected monkeys against Zika infection.
NCI Collaborates with Multiple Myeloma Research Foundation
NCI collaborates with MMRF to incorporate genomic and clinical data into NCI Genomic Data Commons database.
New Imaging Technique in Alzheimer’s Disease
Study confirms new imaging technique corresponds a higher degree of actual brain changes.
Anti-Inflammatory Drugs Could Strengthen Airway Immunity
Mold toxins can weaken the airways' clearing mechanisms and immunity, but PKC inhibitors showed promise as a treatment.
Regulatory RNA Essential to DNA Damage Response
Researchers discover a tumour suppressor is stabilized by an RNA molecule, which helps cells respond to DNA damage.
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
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!