Holzkirchen, 16-10-2014 — /EuropaWire/ — Sandoz is pleased to announce that Generics Bulletin, a newsletter covering commercial and regulatory information for the global generics industry, has awarded the company with “Biosimilars Initiative of the Year”, for its file acceptance of G-CSF (filgrastim) in the US. Sandoz also achieved top-three podium positions in the Company of the Year; Company of the Year – Americas; and Innovation of the Year Awards categories.
On July 24, Sandoz, announced that the FDA accepted its application for filgrastim, making Sandoz the first company to have a filing accepted under the new US biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Outside the US, Sandoz has successfully been marketing filgrastim in more than 30 countries, including the EU, under the brand name ZARZIO® since 2009. Sandoz has established itself as the #1 filgrastim product across Europe with approximately 30% market share, ahead of reference product NEUPOGEN®.
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 170 million patient-exposure days in experience. Sandoz also has an unrivalled pipeline with six molecules in various advanced stages, ranging from Phase III clinical trials to filing acceptance.