Sandoz Biosimilars [1]
Sandoz, a Novartis division, is a pioneer and a global leader in biosimilars. We invest in research and development to improve the lives of patients and liberate healthcare resources through increased access to high-quality, affordable biologics.
Sandoz was the first pharmaceutical company to receive approval of a biosimilar in Europe, Japan and the United States1-3.
Our biosimilars have been used in clinical practice for almost 15 years, are available in 1004 countries and have over 730 million patient-days of experience5.
In addition to our eight marketed biosimilars across immunology, oncology and endocrinology, we also have a leading biosimilars pipeline with more than 15 molecules in various stages of development.
Download our brochure "More than a decade of experience" [2]
The history of Sandoz biosimilars
Sandoz has over 20 years of experience in biosimilar development1. This has equipped us with extensive knowledge and world-class expertise in the development, manufacture and delivery of biosimilar medicines to the healthcare community and patients.
We have a unique heritage in pharmaceutical biotechnology that dates back to the 1940s, with the development of penicillin5. In 1980, Sandoz produced one of the first recombinant proteins, an interferon alfa6.
After initiating the world’s first biosimilar development program in 1996, we went on to receive the world’s first approval of a biosimilar – Omnitrope® (somatropin) – in Europe over a decade ago1. Then, in 2015, Zarxio® (filgrastim) was the first biosimilar to be granted marketing authorization in the US3.
We have an unparalleled heritage in advancing biologic care – longer than any other company.
- European Medicines Agency. Omnitrope® Summary of Product Characteristics. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000607/WC500043695.pdf [3] [Accessed February 2021]
- Pharmaceuticals and Medical Devices Agency. PMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals. Available from: http://www.pmda.go.jp/files/000197722.pdf#page=24 [4] [Accessed February 2021]
- Food and Drug Administration. ZarxioTM Package Insert. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125553lbl.pdf [5] [Accessed February 2021]
- Data on file
- Periodic Safety Update Reports. Data on file.
- Rios, M. A Decade of Microbial Fermentation. Available from: http://www.bioprocessintl.com/upstream-processing/fermentation/a-decade-of-microbial-fermentation-331179/ [6] [Accessed February 2021]