With one of the most comprehensive, nonbranded oncology portfolios in the industry for more than a quarter of a century, our oncology-based biosimilars build upon our history as a leading provider of generic medications for patients with cancer.
Our History
Fresenius Kabi is committed to delivering high-quality biosimilars built on more than 100 years of scientific expertise across numerous therapeutic areas.
Discover our broad capabilities in Pharma, Biopharma, Nutrition, MedTech, and IV therapy
Pharma
Fresenius Kabi offers a leading portfolio of injectable drugs and delivery systems used to treat a broad spectrum of patients. Our product offering includes Oncology, Anesthesia & Analgesia, Anti-Infectives, and many Critical Care therapies that are used in all points of care, including hospitals, long-term care facilities, clinics, and many other alternate site settings.
Biopharma
Our approach to biosimilars is simple, but our work is complex: making advanced, life-changing biologic medicines more accessible to more patients. Fresenius Kabi leverages our global expertise to develop and produce biosimilars.
Nutrition
As pioneers in clinical nutrition, we have innovations that nourish patients of any age. Our parenteral nutrition (PN) products are used to help care for critically and chronically ill patients in hospitals, long-term care facilities, and at home.
MedTech
Our teams are dedicated to supporting your role in healthcare, from donor side to bedside, with infusion systems, apheresis devices, and cell and gene therapy instruments.
IV Therapy
Our growing IV Therapy portfolio features the simply smart Ivenix Infusion System that brings the power of guided workflows, safe and accurate fluid delivery under typical clinical conditions, and complete secondary delivery to your care teams. We also offer IV solutions in our innovative freeflex® and freeflex®+ IV bags designed with the clinician in mind that may help reduce infusion errors, injury, and waste. These offerings combine to make Fresenius Kabi a great choice to help meet your IV Therapy needs.
The Fresenius Kabi impact in biosimilars
Approximately 1 in 10 people currently live with an autoimmune condition, with dramatic increases in incidence likely due to changes in our exposure to environmental factors.¹
As the cancer burden continues to grow globally, physical, emotional, and financial strain is felt by individuals, families, communities, and health systems.²
These realities led Fresenius Kabi to enter the growing biosimilars sector by acquiring a research and development pipeline focused on autoimmune diseases and oncology.
Global impact of Fresenius Kabi biosimilars
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We have secured additional capacity in different geographic areas to ensure that products are readily and consistently available. We have a growing pipeline of biosimilars with candidates in immunology, oncology, and multiple other disease areas.
Biosimilars overview
It has been estimated that biosimilars would save the U.S. healthcare system $54 billion in direct spending on biologic drugs by 2026.¹⁸
By increasing competition in the biologic market, biosimilars may not only reduce healthcare system costs but also foster more patient-centric innovations. These include¹⁹:
- The development of new formulations or injection devices
- More convenient administration routes
- Approaches to help with adherence
Patients can be initiated directly onto a biosimilar drug since the stringent FDA approval process ensures that they pose no efficacy or safety issues beyond those of the reference product.²⁰
Patients already receiving a different biologic treatment can also be changed or “switched” to a biosimilar.²¹
FDA investigators conducted a systematic review and meta-analysis to assess safety outcome differences between participants who switched between a biosimilar and a reference product and participants who did not switch²¹:
- No differences were found in the risk of death, serious adverse events, or treatment discontinuations for individuals who switched between biosimilars and reference products and those who did not
- Immunogenicity data showed similar incidences of antidrug antibodies and neutralizing antibodies between the 2 groups
To obtain FDA regulatory approval, biosimilars must²²:
- Demonstrate high structural and functional similarity to the reference product
- Conduct extensive comparator studies encompassing analytical, nonclinical, and clinical studies
- Assess toxicity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of both biosimilar and reference product
- Only minor differences in clinically inactive components are tolerated. Healthcare providers and patients can therefore expect the same efficacy and safety from a biosimilar as they can from the reference product
- Undergo any additional specific safety monitoring required for the reference product following approval
Yes. “Extrapolation” is possible when the total evidence in the biosimilar application supports a demonstration of biosimilarity for at least one of the reference product’s indications.¹¹
This concept is critical to the goals of an abbreviated pathway, improving access and options at a potentially lower cost.
Extrapolation is based on¹¹:
- All available data and information in the biosimilar application;
- Previous safety and efficacy findings by the FDA for other approved indications of the reference product;
- Knowledge and consideration of various scientific factors for each indication, including mechanism(s) of action, PK, PD, efficacy, safety, and immunogenicity of the reference product in each of its approved indications.
The FDA works with biosimilar manufacturers during biosimilar development to determine the data required to support extrapolation.
FDA, U.S. Food and Drug Administration; PD, pharmacodynamics; PK, pharmacokinetics.
References:
1. Conrad N, Misra S, Verbakel JY, et al. Incidence, prevalence, and co-occurrence of autoimmune disorders over time and by age, sex, and socioeconomic status: a population-based cohort study of 22 million individuals in the UK. Lancet. 2023;401(10391):1878-1890.
2. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-249.
3. Fresenius Kabi receives U.S. FDA approval for biosimilar Idacio® (adalimumab). News Release. Fresenius Kabi. December 14, 2022. Accessed March 15, 2025.
4. Fresenius Kabi receives European Commission approval for its pegfilgrastim biosimilar Stimufend®. News Release. Fresenius Kabi. March 30, 2022. Accessed May 6, 2025.
5. Fresenius Kabi launches biosimilar Stimufend® (pegfilgrastim-fpgk) in the U.S. News Release. Fresenius Kabi. February 26, 2023. Accessed May 6, 2025.
6. Stimufend® (pegfilgrastim-fpgk) a Fresenius Kabi biosimilar receives FDA approval. News Release. Fresenius Kabi. September 6, 2022. Accessed March 15, 2025.
7. Fresenius Kabi completes majority stake acquisition of mAbxience holding S.L., significantly enhancing presence in high-growth biopharmaceuticals market. News Release. Fresenius Kabi. August 1, 2022. Accessed May 6, 2025.
8. Fresenius Kabi’s biosimilar Tyenne® (tocilizumab-aazg) becomes the first IV and subcutaneous tocilizumab biosimilar approved by the FDA. News Release. Fresenius Kabi. March 7, 2024. Accessed March 15, 2025.
9. Fresenius Kabi and Formycon receive U.S. FDA approval for biosimilar Otulfi™ (ustekinumab-aauz). News Release. Fresenius Kabi. September 30, 2024. Accessed May 5, 2025.
10. Fresenius receives FDA approval for their denosumab biosimilars and secures global settlement agreement. March 27, 2025. Accessed May 5, 2025.
11. Declerk P, Danesi R, Petersel D, Jacobs I. The language of biosimilars: Clarification, definitions, and regulatory aspects. Drugs. 2017;77(6):671-677.
12. Janjigian YY, Bissig M, Curigliano G, Coppola J, Latymer M. Talking to patients about biosimilars. Future Oncol. 2018;14(23):2403-2414.
13. Thill M, Thatcher N, Hanes V, Lyman GH. Biosimilars: what the oncologist should know. Future Oncol. 2019;15(10):1147-1165.
14. U.S. Food and Drug Administration (FDA). Facts about generic drugs. Accessed May 6, 2025.
15. Biosimilars Forum. Why biosimilars. 2025. Accessed May 6, 2025.
16. Blackstone EA, Fuhr JP. The economics of biosimilars. Am Health Drug Ben. 2013;6(8):469-478.
17. U.S. Food and Drug Administration (FDA). Biosimilar Development Process. Accessed March 14, 2025.
18. Mulcahy AW, Hlávka JP, Case SR. Rand Corporation. Biosimilar Cost Savings in the United States; Initial Experience and Future Potential. Published 2017. Accessed May 6, 2025.
19. Dutta B, Huys I, Vulto AG, et al. Identifying key benefits in European off-patent biologics and biosimilar markets: It is not only about price! BioDrugs. 2020;34(2):159-170.
20. U.S. Food and Drug Administration (FDA). Biosimilar and Interchangeable Biologics: More Treatment Choices, Updated August 17, 2023. Accessed May 6, 2025.
21. U.S. Food and Drug Administration (FDA). Safety outcomes when “switching” between biosimilars and reference products. Updated December 5, 2023. Accessed May 6, 2025.
22. U.S. Food and Drug Administration (FDA). Biosimilar development process. Accessed March 14, 2025.