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Our Biosimilars products portfolio 

Our Biosimilars portfolio focuses on autoimmune diseases and oncology, and we have several candidates in various development phases in these therapy areas.

At Fresenius Kabi, we are committed to providing valued biologic treatments through the development of immunology and oncology therapies in our expanding biosimilars portfolio.

Our autoimmune disease (immunology) portfolio includes biosimilars of adalimumab, tocilizumab, rituximab, and ustekinumab. 

Our biosimilar oncology portfolio includes a biosimilar of pegfilgrastim, and rituximab.

In addition, we have a biosimilar of denosumab in the osteoporosis therapeutic area and multiple candidates in early-phase development, in both autoimmune and oncology therapy areas.

Biopharma Pipeline October 2023

Autoimmune Diseases

The immune system plays a vital role in protecting the body from disease-causing organisms (pathogens). When confronted with a foreign substance (‘non-self’), a healthy immune system will produce antibodies to fight off the unwanted invader.  

Sometimes, however, the immune system cannot tell the difference between body cells (‘self’) and foreign cells, causing the body to mistakenly attack itself. This is referred to as autoimmune disease.    

There are over 80 identified autoimmune diseases, include rheumatoid arthritis, Crohn’s disease, and psoriasis 1. A wide range of body parts and almost any organ system can be affected by autoimmune diseases 1

It is estimated that about 4% of the global population is affected by at least one autoimmune disease, a figure that is increasing 1,3. The causes of autoimmune diseases are multifactorial; among them, genetic background, immune regulation, environment, lifestyle habits (e.g., smoking) have been described as major risk factors 4. As hormones impact immune regulation, women are generally 3 to 4 times more susceptible to developing an autoimmune disease than men 4

How can biosimilars help patients with autoimmune diseases?

Biosimilars can be used in the management of autoimmune diseases by directly inhibiting specific immune cells or molecules regulating immune responses to reduce inflammation and improve the quality of life 5

1.    National Stem Cell Foundation (NSCF). Autoimmune Disease. https://nationalstemcellfoundation.org/glossary/autoimmune-disease/ (accessed January 2023)
2.    Lerner A, Jeremias P, Matthias T. The World Incidence and Prevalence of Autoimmune Diseases is Increasing. International Journal of Celiac Disease. 2015;3(4):151-155.
3.    Cleveland Clinic. Autoimmune Diseases. Last reviewed July 21, 2021. https://my.clevelandclinic.org/health/diseases/21624-autoimmune-diseases (accessed January 2023)
4.    Padda IS, Bhatt R, Rehman O, Parmar M. Biosimilars Use In Medicine For Inflammatory Diseases. In: StatPearls. Treasure Island (FL): StatPearls Publishing; November 30, 2022. https://www.ncbi.nlm.nih.gov/books/NBK574572


Cancer is still a leading cause of death globally1. In addition to the devastation caused to patients and their families, the prevalence of the disease places a heavy economic burden on healthcare systems2,3. By 2025, global spending on cancer drugs is expected to reach $269bn – an increase of 64% in just 5 years4.  
Despite advances in cancer research, cost remains a major barrier to treatment5. Committed to providing wider access to affordable medicines, Fresenius Kabi offers an extensive oncology portfolio, including biosimilars.
Broadening the use of biosimilars in oncology is thought to help reduce the cost of treatment and is supported by several international organizations, including ESMO and ASCO in their clinical guidance to healthcare professionals6-8.

The role of biosimilars in the holistic approach to cancer care

Fresenius Kabi has been developing a holistic approach – where biosimilars play a key role – to support cancer patients and their families. In curative treatment care, biosimilars can help fight against cancer cells while in supportive treatment care they can stimulate specific white blood cells and reduce the risk of infections.

1.    World Health Organization (WHO). Cancer. Available at www.who.int/health-topics/cancer (accessed January 2022).
2.    Guy GP Jr, Ekwueme DU, Yabroff KR, et al. Economic burden of cancer survivorship among adults in the United States. J Clin Oncol. 2013;31(30):3749-3757. 
3.    Hofmarcher T, Lindgren P, Wilking N, Jönsson B. The cost of cancer in Europe 2018. Eur J Cancer. 2020;129:41-49. doi:10.1016/j.ejca.2020.01.011
4.    Global Oncology Trends 2021. IQVIA Institute for Human Data Science. 2021. Available at https://www.iqvia.com/insights/the-iqvia-institute/reports/global-oncology-trends-2021 (accessed January 2022).
5.    World Health Organization (WHO). Pricing of cancer medicines and its impacts. 2018. Available at https://apps.who.int/iris/handle/10665/277190 (accessed January 2022).
6.    Tabernero J, Vyas M, Giuliani R, et al. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017;1(6):e000142. Published 2017 Jan 16. 
7.    Nahleh Z, Lyman GH, Schilsky RL, et al. Use of Biosimilar Medications in Oncology. JCO Oncol Pract. 2022;18(3):177-186. 
8.    Lyman GH, Balaban E, Diaz M, et al. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018;36(12):1260-1265. 

The information on this page is intended for healthcare professionals based outside of the U.S. so that they may learn about our portfolio offering in their region.