Sandoz, a Novartis division, is a pioneer and a global leader in biosimilars. We invest in research and development to improve patient lives 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 24 molecules in various stages of development1.

Our biosimilars have been used in clinical practice for over 15 years, and are available across the globe with over 1,300 million patient-days of experience2.

Unparalleled Heritage

Siluettes from different target groups

> 1 decade

Marketing of biosimilars since the first biosimilar was approved (3)

Gloves used in a laboratory

> 2 decades

Biosimilar development experience since initiating the first biosimilar development program (4)

Glasses for use in the laboratory

> 4 decades

Developing recombinant proteins (5)

Biotechnology experience dating back to the manufacturing of penicilin

> 7 decades

Biotechnology experience dating back to the manufacturing of penicilin (6)

Different biosimilar milestones from 1996 - 2006
  1. Sandoz data on file. [Accessed November 2022] 
  2. Sandoz PSUR data on file. [Accessed November 2022]
  3. European Medicines Agency (EMA). Omnitrope® Summary of Product Characteristics. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Inf…  [Accessed December 2022]​
  4. European Medicines Agency. Erelzi® Summary of Product Characteristics. Available from: https://www.ema.europa.eu/medicines/human/EPAR/Erelzi  [Accessed November 2022]​
  5. European Medicines Agency. Binocrit® Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/binocrit   [Accessed November 2022]​
  6. European Medicines Agency. Zarzio® Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/zarzio [Accessed November 2022]​
  7. European Medicines Agency. Ziextenzo® Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo  [Accessed November 2022]​
  8. European Medicines Agency. Rixathon® Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/rixathon  [Accessed November 2022]​
  9. European Medicines Agency. Hyrimoz® Summary of Product Characteristics. Available from:https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz [Accessed November 2022]​
  10. European Medicines Agency. Zessly® Summary of Product Characteristics. Available https://www.ema.europa.eu/en/medicines/human/EPAR/zessly [Accessed November 2022]​
  11. Australian Government. Department of Health, Therapeutic Goods Administration. Public Summary for Omnitrope® (Somatropin) [Accessed December 2022].
  12. McCamish M and US FDA Arthritis Committee. GP2015 introduction and concept. 2016. Available from: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMater…  [Accessed December 2022]
  13. Rios, M. A Decade of Microbial Fermentation. BioProcess International. Available  from: http://www.bioprocessintl.com/upstream-processing/fermentation/a-decade…   [Accessed December 2022].
  14. Bud, R. 2007. Penicillin: Triumph and Tragedy. Great Britain: Oxford University Press.
  15. European Medicines Agency (EMA). Omnitrope® Summary of Product Characteristics. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Inf…  [Accessed December 2022].
  16. Center for Drug Evaluation and Research. Approval Letter: Omnitrope®. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021426s000_APPR… [Accessed December 2022]. 
  17. 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 December 2022].
  18. Generics and Biosimilars Initiative. Biosimilars approved in Canada. Available from: https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-… [Accessed December 2022].

* No specific biosimilar pathway existed at the time in Australia, and so Omnitrope® was approved under the normal regulatory pathway in 2004. As biosimilar indication had not yet been established, the product was not established as a biosimilar at the time.
† No specific biosimilar pathway existed at the time in the US, and so Omnitrope® was approved under the normal regulatory pathway in 2007. Zarxio® was the first biosimilar to be approved under the new BPCIA pathway in 2015.