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

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

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 3,000+ scientific posters on ePosters
  • More than 4,400+ 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 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
Understanding Female HIV Transmission
Glowing virus maps points of entry through entire female reproductive tract for first time.
Soy Shows Promise as Natural Anti-Microbial Agent
Soy isoflavones and peptides may inhibit the growth of microbial pathogens that cause food-borne illnesses, according to a new study from University of Guelph researchers.
Designing Better Drugs
A rational drug engineering approach could breathe new life into drug development.
AstraZeneca to Sequence 2 Million Genomes in Search for New Drugs
Company launches integrated genomics approach which aims to transform drug discovery and development.
Factors Influencing Influenza Vaccine Effectiveness Uncovered
The long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited, new research suggests.
Study Finds Factors That May Influence Influenza Vaccine Effectiveness
Researchers at NIH have suggested that the long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited.
New Model to Enhance Zika Virus Research
The model will allow researchers to better understand how the virus causes disease and aid in the development of antiviral compounds and vaccines.
Improving Flu Vaccine Effectiveness
NIH study finds factors that may influence influenza vaccine effectiveness.
BMS’s Opdivo Clinical Trial Shows Promise
Safety profile of the combination regimen from CheckMate -069 was consistent with previously reported studies and adverse events were managed using established safety algorithms.
CNS Inflammation: A Pathway and Possible Drug Target
Scientists have long known that the central nervous system (CNS) has a remarkable ability to limit excessive inflammation in the presence of antigens or injury, but how it works has been unclear.
SELECTBIO

SELECTBIO Market Reports
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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,400+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!