FDA accepts Sandoz application for biosimilar filgrastim

August 4, 2014 8:45 AM

Sandoz, a Novartis Group company, announced last week that the US Food and Drug Administration (FDA) has accepted its Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

The reference product – Amgen’s NEUPOGEN® – is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.

“This filing acceptance represents a significant step toward making high-quality biologics more accessible in the US and we applaud FDA for its progress in making this a reality,” said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. “As they’ve done in Europe and other highly-regulated markets around the world, biosimilars are poised to increase US patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall healthcare system.”

Under the brand name ZARZIO®, the Sandoz biosimilar filgrastim has been marketed in more than 40 countries outside the US, generating nearly six million patient-exposure days of experience. ZARZIO is the number one biosimilar filgrastim globally and is the leading daily G-CSF in Europe with 30 percent volume market share.

Sandoz is the global market leader with over 50% share of all biosimilars approved in the highly-regulated markets of Canada, Europe, Japan and Australia. Sandoz currently markets three biosimilars outside the US; each of which occupies the #1 biosimilar position in its respective category. Sandoz biosimilars are sold in over 60 countries and have generated over 200 million patient-exposure days in experience. Sandoz also has six molecules in Phase III clinical trials/filing preparation.

Source: Sandoz press release

Leave a Reply

Twitter ID
(ID only. No links or "@" symbols)


Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?

Suggestions?

Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!