Sandoz Biosimilars " >Sandoz Biosimilars

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.

With 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.

After initiating the world’s first biosimilar development program 25 years ago, we went on to receive the world’s first approval of a biosimilar in Europe in 20061. Then, in 2009, we received the first marketing authorization of biosimilars in Japan and Canada2,3 and opened the US market with the first biosimilars approval in 20154.

Our biosimilars have been used in clinical practice for over 15 years, are available in approx. 1005 countries with over 970 million patient-days of experience6.

Find out more in our "More than a decade of experience" brochure (PDF, 0.4 MB)

Unparalleled heritage

We have a unique heritage in pharmaceutical biotechnology and advancing biologic care, that dates back to the 1940s with the development of penicillin. In 1980, Sandoz produced one of the first recombinant proteins, an interferon alfa7. Sandoz also has over 25 years of experience in biosimilar development1 – longer than any other company. 

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.

>1 decade Marketing of biosimilars1
2 decades Biosimilar development experience since initiating the first biosimilar development programme1
3 decades Developing recombinant proteins7
7 decades Biotechnology experience dating back to the 1940s and the development of penicillin 
  1. 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 [Accessed November 2021]
  2. 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 [Accessed November 2021]
  3. Generics and Biosimilars Initiative. Biosimilars approved in Canada. Available from: http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada. [Accessed November 2021].
  4. Food and Drug Administration. ZarxioTM Package Insert. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125553lbl.pdf [Accessed November 2021
  5. Sandoz Data on File
  6. Periodic Safety Update Reports. Data on file.
  7. Rios, M. A Decade of Microbial Fermentation. Available from: http://www.bioprocessintl.com/upstream-processing/fermentation/a-decade-of-microbial-fermentation-331179/ [Accessed November 2021]
  8. Bud, R 2007. Penicillin: Triumph and Tragedy: Great Britain: Oxford University Press [Accessed November 2021]

Source URL: https://www.sandoz.com/our-work/biopharmaceuticals/sandoz-biosimilars

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