FDA accepts Sandoz application for biosimilar filgrastim

Novartis International AG / FDA accepts Sandoz application for biosimilar filgrastim . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Sandoz is the first company to announce it has filed for approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
• FDA's acceptance of Sandoz's filing is an important first step in increasing US patient access to affordable, high-quality biologics
• Sandoz is a global leader in biosimilars with over 50% share of the global biosimilars market [1]

Holzkirchen, July 24, 2014 - Sandoz, a Novartis Group company, announced today 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 a pioneer in biosimilars and 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 an unrivalled pipeline with several molecules in various stages of development. Sandoz now has six molecules in Phase III clinical trials/filing preparation, more than any other company in the industry.