Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
Become a Member | Sign in
Home>News>This Article

Sandoz Receives Japanese Approval for Biosimilar Filgrastim

Published: Monday, March 24, 2014
Last Updated: Monday, March 24, 2014
Bookmark and Share
Approval paves the way for this oncology medicine to be made available to oncology patients in Japan.

Sandoz announced that Sandoz Japan has received marketing authorization approval for its biosimilar filgrastim (Kyowa Hakko Kirin’s GRAN®). The product, which will be marketed as Filgrastim BS Injection 75 µg/150 µg/ 300 µg Syringe “Sandoz”, is the second Sandoz biosimilar to be approved in Japan. 

Filgrastim is used with certain cancer patients to accelerate recovery of infection-fighting white blood cells after chemotherapy (prevention of neutropenia) and is also used to stimulate mobilization of hematopoietic stem cells for collection and transplantation. Sandoz Filgrastim is approved in Japan for the same range of indications as the reference product GRAN and offers patients comparable quality, safety and efficacy combined with potentially greater cost-effectiveness for the healthcare system.

"We are pleased to receive our second biosimilar approval in Japan," said Junichi Nakamichi, Country Head, Sandoz Japan. "This product has already been used in clinical practice in over 40 countries around the world under the brand name of Zarzio® and we look forward to making this product available to patients and physicians in Japan."

Zarzio is the number one biosimilar filgrastim globally and in 2013 it became the most prescribed Daily GCSF treatment in Europe ahead of originator products from Amgen and Chugai.

Sandoz is the only company with marketing authorization for more than one biosimilar medicine in the Japanese market. In 2009, the company’s human growth hormone Omnitrope® (Pfizer’s Genotropin®) became the first-ever biosimilar medicine to be approved and launched in Japan.

Sandoz is the global leader and pioneer in developing, manufacturing and commercializing biosimilars. Sandoz markets three biosimilar products, all of which are #1 in their respective categories globally. Sandoz’ biosimilars are collectively sold in over 50 countries and have generated over 100 million patient exposure days of experience. Sandoz has an industry-leading biosimilars pipeline with six molecules in the Phase III clinical trials/registration prep stage including biosimilar versions of leading biologics such as adalimumab (AbbVie’s Humira®), etanercept (Amgen’s Enbrel®) and rituximab (Roche’s Rituxan®/MabThera®).

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

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 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 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
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
Speeding Up the Process of Making Vaccines
System uses a freeze-dry concept to develop "just-add-water" solution.
Surprising Trait Found in Anti-HIV Antibodies
Scientists at The Scripps Research Institute (TSRI) have new weapons in the fight against HIV.
New Method Identifies Up to Twice as Many Proteins and Peptides
An international team of researchers developed a method that identifies up to twice as many proteins and peptides in mass spectrometry data than conventional approaches.
The Do’s and Don’ts of SPR Experiments
Surface Plasmon Resonance (SPR) is a technique that is becoming more widely used, particularly by anyone who wants to obtain accurate on (association) and off (dissociation) rates for biomolecular binding.
Genetically Engineering Algae to Kill Cancer Cells
New interdisciplinary research has revealed the frontline role tiny algae could play in the battle against cancer, through the innovative use of nanotechnology.
Novel Stem Cell Line Avoids Risk of Introducing Transplanted Tumors
Progenitor cells might eventually be used to repair or rebuild damaged or destroyed organs.
Single Vaccine for Chikungunya, Related Viruses May be Possible
What if a single vaccine could protect people from infection by many different viruses? That concept is a step closer to reality.
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.
Molecule Proves Key to Brain Repair After Stroke
Scientists found that a molecule known as growth and differentiation factor 10 (GDF10) plays a key role in repair mechanisms following stroke.
Circadian Clock Controls Insulin and Blood Sugar in Pancreas
Map of thousands of genes suggests new therapeutic targets for diabetes.

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