Sandoz Biosimilar Portfolio and Pipeline

Sandoz, a Novartis division, has a leading biosimilar portfolio and pipeline in immunology, oncology and endocrinology.

Portfolio

Sandoz biosimilar Indication area
Omnitrope® [somatropin] Endocrinology
Erelzi® [etanercept] Immunolgoy (rheumatology, dermatology)
Binocrit® [epoetin alfa] Oncology (supportive cancer care)
Zarzio®/ Zarxio® [filgrastim] Oncology (supportive cancer care)
Ziextenzo® [pegfilgrastim] Oncology (supportive cancer care)
Rixathon® [rituximab] Oncology (blood cancers), Immunology (rheumatology)
Hyrimoz® [adalimumab] Immunology (rheumatology, gastroenterology, dermatology)
Zessly® [infliximab] Immunology (rheumatology, gastroenterology, dermatology)

Pipeline

In-House

Project/

Compound		 Potential indication/

Disease area		 Submission

Status		 Current

Phase		 News Update

GP2411

(denosumab)

Osteoporosis, skeletal-related in bone met. pts (same as reference medicine)

US

EU

Phase III

Phase III
  • First patient treated July 2019

Collaborations

Biocon: In global partnership with Asia’s premier biopharmaceuticals company several biosimilars are under development in immunology and oncology for patients worldwide.

Gan & Lee: Under our supply and commercialization partnership with Gan & Lee, a leading insulin supplier headquartered in China with more than 20 years of experience in insulins, we are aiming to bring to market biosimilar versions of glargine, lispro and aspart insulins.

EirGenix: The agreement between Sandoz and EirGenix, Inc, a biotechnology manufacturing and development company that aspires to provide high-quality medicines for individuals and society, aims to bring to market a proposed biosimilar trastuzumab.

Polpharma Biologics: Sandoz entered into a global commercialization agreement for a proposed natalizumab biosimilar with Polpharma Biologics to commercialize and distribute the medicine in all markets upon approval, through an exclusive global license. Under the agreement, Polpharma Biologics will maintain responsibilities for development, manufacturing and supply of proposed biosimilar natalizumab. The medicine is in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis.

 

  1. European Medicines Agency. Ziextenzo European Public Assessment Report (EPAR). Available at: https://www.ema.europa.eu/medicines/human/EPAR/ziextenzo#product-information-section (link is external). [Accessed March 2019]
  2. J. de Naurois, on behalf of the ESMO Guidelines Working Group. Management of febrile neutropenia: ESMO Clinical Practice Guidelines. Annals of Oncology, Volume 21, Issue suppl_5, 1 May 2010, Pages v252-v256, https://doi.org/10.1093/annonc/mdq196 (link is external) Available at: https://academic.oup.com/annonc/article/21/suppl_5/v252/193896 (link is external). [Accessed March 2019]

Immunology

Immune system disorders affect hundreds of millions of people worldwide and can severely impact quality of life and even life expectancy1,2,3. These debilitating disorders include those affecting the joints (such as rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis), the skin (such as psoriasis) and the gut (such as Crohn’s disease and ulcerative colitis).

Sandoz is the long-term partner supporting rheumatologists, dermatologists and gastroenterologists in advancing patient care without compromise. Our proven expertise and experience in biosimilars, provides high-quality affordable medicines in this therapy area.

We are committed to providing life-changing immunology therapies and have a robust biosimilar immunology portfolio with Erelzi®4, Hyrimoz®5, Zessly®6  and Rixathon®7 already marketed in Europe.

Learn more about the wider Novartis Group’s involvement in immunology

 

  1. Gibofsky A. Overview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis. Am J Manag Care. 2012 Dec;18(13 Suppl):S295-302.
  2. World Health Organization. Global report on psoriasis 2016. Available at: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf [Accessed January 2019]
  3. Gladman D et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis 2005;64:ii14-ii17 doi:10.1136/ard.2004.032482
  4. European Medicines Agency. Erelzi® Summary of Product Characteristics. Available from: https://www.ema.europa.eu/medicines/human/EPAR/Erelzi  [Accessed January 2019]
  5. European Medicines Agency. Hyrimoz® Summary of Product Characteristics. Available from:https://www.ema.europa.eu/en/medicines/human/EPAR/hyrimoz [Accessed January 2019]
  6. European Medicines Agency. Zessly® Summary of Product Characteristics. Available https://www.ema.europa.eu/en/medicines/human/EPAR/zessly [Accessed January 2019]
  7. European Medicines Agency. Rixathon® Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/rixathon  [Accessed January 2019]

Endocrinology

Endocrinology diseases fall under a broad category of over or underproduction of hormones, altered tissue response to hormones or tumors arising from endocrine tissue1. Some of these disorders can affect metabolism such as diabetes mellitus - with steadily increasing prevalence worldwide-2, impair fertility and growth.

Sandoz is committed to the Endocrinology community supporting healthcare professionals and patient care givers. Sandoz is also focused on increasing physicians and patient access to broader options for high-quality biologic medicines in Endocrinology.

We currently market Omnitrope® (recombinant human growth hormone, rhGH, Somatropin), which was approved by the EMA in 2006, as the world’s first biosimilar medicine.3

In addition, we are working on bringing multiple insulin biosimilars to the market in the next couple of years.4

 

  1. Melmed S, et al. (eds). Williams Textbook of Endocrinology. 13th edition. Philadelphia: Elsevier; 2016
  2. World Health Organization. (‎2016)‎. Global report on diabetes: executive summary. World Health Organization. https://apps.who.int/iris/handle/10665/204874 [Accessed February 2019]
  3. European Medicines Agency. Omnitrope® Summary of Product Characteristics. Available from: https://www.ema.europa.eu/documents/product-information/omnitrope-epar-p... [Accessed February 2019]
  4. Sandoz International GmbH. Sandoz enters into commercialization and supply agreement for insulin biosimilars, anticipating growing demand as diabetes burden rises. Available from: https://www.sandoz.com/news/media-releases/sandoz-enters-commercializati.... [Accessed February 2019]

Oncology

Cancer is one of the leading causes of death and places a significant and growing burden on healthcare systems around the world1.

Sandoz is committed to increasing physician and patient access to broader options for quality cancer treatments that make up the foundation of cancer care. Biosimilar treatment options could free up resources, which can be redeployed for innovation, access and new interventions within healthcare systems to support and manage the burden of oncology care.

We currently market Zarzio®2 / Zarxio®2, Binocrit®3 and Ziextenzo®4, used in supportive cancer care and Rixathon®5 to treat blood cancers. Sandoz also has a robust portfolio of investigational oncology biosimilars it is bringing to market in the future.

In addition to biosimilars, Sandoz oncology medicines have a presence in more than 93 countries and provide therapy options across the 10 most prevalent tumor types including Breast cancer, Prostate cancer, Colorectal cancer, Lung cancer, Blood cancer.

With a leading global generic oncology portfolio of >50 products, from chemotherapy, via hormones and supportive care to targeted therapies, Sandoz has been manufacturing oncology treatments for over 30 years, with a strong focus on delivering medicines of the highest purity and quality and expanding our portfolio to ensure we continue to provide a comprehensive range of oncology products.

Sandoz is committed to playing a key role in achieving global healthcare goals, by pioneering new approaches to drive increased access to healthcare worldwide.

Beyond providing high-quality affordable medicines, Sandoz is also committed to improve health care infrastructures worldwide through various partnerships and dedicated teams in many countries interacting daily with health care practitioners, providers, payers and patients.

Learn more about Novartis in oncology

 

  1. World Health Organization. World Cancer Report 2014. Available at: http://www.who.int/mediacentre/factsheets/fs297/en/ [Accessed January 2019]
  2. European Medicines Agency. Zarzio® /Zarxio® Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/zarzio [Accessed January 2019]
  3. European Medicines Agency. Binocrit® Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/binocrit   [Accessed January 2019]
  4. European Medicines Agency. Zarzio® Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/zarzio  [Accessed January 2019]
  5. European Medicines Agency. Rixathon® Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/rixathon  [Accessed January 2019]

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