Sandoz Leadership

Sandoz Leadership

Sandoz is the pioneer and global leader of biosimilars1,2

First approved biosimilar icon of man and 1st

First approved biosimilar in the US and worldwide1,3

  • First manufacturer in the world to have a biosimilar approved and commercialized1,4,5
  • First manufacturer to navigate the US FDA pathway for approval1,4,5
  • First manufacturer to receive FDA approval for 2 biosimilars1,4,5
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Long history of biosimilar development

  • 30+ years of biologic development6
  • 18+ years of developing biosimilars4
  • 8+ years of biosimilar post-marketing surveillance4
 

Sandoz has produced high-quality biologic products for over 35 years

1980
Sandoz develops one of the first recombinant proteins.6
1996
Sandoz pioneers the biosimilar development program. Sandoz and Ciba merge to create Novartis.4,7
2006
Sandoz launches the first product approved under the European Union's new regulatory pathway for biosimilars.8,9
2014
Sandoz is the first to file under the new US FDA biosimilar approval pathway, leading to the first US-approved biosimilar.1,4,5
2015
Sandoz receives approval of the first biosimilar in the US.1
2016
Sandoz receives approval for its second biosimilar in the US, becoming the only company with 2 FDA-approved biosimilars.10

Watch Sandoz Biosimilars: A Decade of Experience

 

Sandoz has produced high-quality biologic products for over 35 years

1980
Sandoz develops one of the first recombinant proteins.6
1996
Sandoz pioneers the biosimilar development program. Sandoz and Ciba merge to create Novartis.4,7
2006
Sandoz launches the first product approved under the European Union's new regulatory pathway for biosimilars.8,9
2014
Sandoz is the first to file under the new US FDA biosimilar approval pathway, leading to the first US-approved biosimilar.1,4,5
2015
Sandoz receives approval of the first biosimilar in the US.1
2016
Sandoz receives approval for its second biosimilar in the US, becoming the only company with 2 FDA-approved biosimilars.10

Watch Sandoz Biosimilars: A Decade of Experience

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Real-world experience

  • Approved biosimilar products in 75+ countries11
  • 250 million patient-exposure days worldwide12
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Sandoz has biosimilars in various stages of development for13,14:

  • Dermatology
  • Gastroenterology
  • Nephrology
  • Oncologic supportive care
  • Oncology
  • Rheumatology

References: 1. FDA Biosimilar Approval March 6, 2015 [press release]. US Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm . Published March 6, 2015. Accessed November 30, 2016. 2. PRNewswire.com. Pharma leader series: top 25 biosimilar drug manufacturers 2013-2023. http://www.prnewswire.com/news-releases/pharma-leader-series-top-25-biosimilar-drug-manufacturers-2013-2023-230654201.html. Published November 30, 2016. Accessed November 30, 2016. 3. Generics and Biosimilars Initiative. Biosimilars approved in Europe. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Published May 6, 2016. Accessed November 30, 2016. 4. US Food and Drug Administration. FDA Oncologic Drugs Advisory Committee Meeting: January 7, 2015. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM428782.pdf. Accessed November 30, 2016. 5. Lexology.com. FDA accepts the first biosimilar application under the BPCIA. http://www.lexology.com/library/detail.aspx?g=4198c549-d545-4dab-ba1e-472038ffe42a . Accessed November 30, 2016. 6. BioProcess International. A decade of microbial fermentation. http://www.bioprocessintl.com/upstream-processing/fermentation/a-decade-of-microbial-fermentation-331179. Published June 1, 2012. Accessed November 30, 2016. 7. Pmlive.com. This month in 1996: Ciba-Geigy and Sandoz merge. http:// www.pmlive.com/pharma_news/this_month_in_1996_ciba-geigy_and_sandoz_merge_553502. Published March 17, 2014. Accessed November 30, 2016. 8. Berghout A. Clinical programs in the development of similar biotherapeutic products: rationale and general principles. Biologicals. 2011;39(5):293-296. 9. EMA European Medicines Agency. Somatropin. Authorisation details. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/ medicines/000607/human_med_000946.jsp&mid=WC0b01ac058001d124. Accessed November 30, 2016. 10. FDA Biosimilar Approval August 30, 2016 [press release]. US Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm. Published August 30, 2016. Accessed November 30, 2016. 11. Data on file. Sandoz Biosims in Over 75 Countries. Sandoz Inc; July 2016. 12. Data on file. Periodic Safety Update Report 7 (PSUR 7) for Erythropoietin-Containing Products. Sandoz International GmbH; October 2015. 13. ClinicalTrials.gov. Accessed November 24, 2014. 14. Data on File. Sandoz Biosimilar Development in Gastroenterology. Sandoz Inc; August 2016.