Our Products & Expertise

Fresenius Kabi’s experience plays a significant role in why we are BioSpecialized®

Marketed products

Our FDA approved biosimilars that ultimately provide the ability to help more patients.

An FDA-approved biosimilar to Neulasta® (pegfilgrastim)

Our pipeline

Reference Biologic
Early Stage Development
Late Stage Development
Filed for Approval
FDA Approved
rituximab*
Rituxan®

pegfilgrastim-fpgk
On-Body Injector*

Neulasta Onpro®
ustekinumab*
Stelara®
denosumab*
Xgeva®
denosumab*
Prolia®

Multiple candidates*

Our pipeline

Product

Reference Biologic

Stage

Neulasta®

FDA Approved

Humira®

FDA Approved

Actemra®

FDA Approved

rituximab*

Rituxan®
Filed for Approval
pegfilgrastim-fpgk
On-Body Injector*
Neulasta Onpro®
Late Stage Development

ustekinumab*

Stelara®
Late Stage Development

denosumab*

Xgeva®
Late Stage Development

denosumab*

Prolia®
Late Stage Development

Multiple candidates*

Early Stage Development

*Products pending FDA Approval. The safety or effectiveness of the products has not been established.

Advanced science, manufacturing and support for biosimilars

Manufacturing and supply network

Why and how we aim to make advanced medicines available to everyone.

Oncology experience

Discover a comprehensive oncology portfolio developed over the last 25 years

Immunology expertise

Learn about our long-term commitment to auto-immune therapies in the development of immunology biosimilars.

Our U.S. Presence

Our U.S. presence continues to grow with nearly $1 billion invested in pharmaceutical manufacturing facilities over the past few years.

Our Manufacturing and supply network

Our Manufacturing and Supply Network

Made up of 90 science, manufacturing and R&D centers around the globe, Fresenius Kabi is committed to making drug development more efficient. We use leading manufacturing technologies and innovative processes to replace slow and expensive legacy methods. Our extensive experimentation, analytical characterization and computational simulations ensure high-quality products from batch to commercial scale.

Our five-step process for biosimilar development

Step 1

Cell Line Development

Selecting and optimizing a host cell line to produce a biological drug that closely resembles the reference product.
Step 2

Upstream Process Development

Optimizing the production of biological molecules using cell cultures, fermentation, and genetic engineering techniques.
Step 3

Downstream Process Development

Optimizing and scaling up purification and formulation techniques to ensure the production of highly similar and safe biological drugs.
Step 4

Analytics

The objective of analytics is to test the structural attributes of the biosimilar molecule and the originator and develop an in-depth understanding of its quality.
Step 5

In Vitro Nonclinical Pharmacology

Studying the effects of drugs on isolated cells or tissues outside of a living organism to assess their pharmacological properties and potential therapeutic benefits.

Oncology Experience

At Fresenius Kabi, we have one of the most comprehensive, non-branded oncology portfolios in the industry and have been supplying the U.S. with oncology medicines for more than a quarter of a century.

60+

Unique oncology product codes, 12 products in market leading position*

460+

Chemotherapy regimens supported by one or more Fresenius Kabi products**

220+

Chemotherapy regimens that can be supported entirely by Fresenius Kabi products**

14,000+

U.S. customers used oncology products from Fresenius Kabi in 2020

20+

Oncology drugs in development, biosimilars, and generics

A leading manufacturer

in transfusion medicine products and cell processing equipment

The role of biosimilars in oncology

By 2030, the total spending for cancer care in the U.S. is projected to be around $246 billion. As cancer care spending continues to grow, so does patient cost-sharing.1 A 2017 report found that the average per-patient out-of-pocket costs for the first year following a cancer diagnosis were between $3,600 and $5,500 depending on cancer type, treatment required and insurance coverage.2

In their 2018 statement on biosimilars, the American Society of Clinical Oncology (ASCO) acknowledged that biosimilars will play an important role in the future care of patients with cancer and will improve access to medicines.3 The growing availability of oncology biosimilars could help to provide more treatment options, increase access to life-saving medicines and potentially lower treatment costs for both patients and payers.4

As of May 2022, there are 36 FDA-approved biosimilar products in the U.S., many of which are utilized in oncology or supportive care for patients with cancer.5,6 With increased experience and adoption of oncology biosimilar products, the substantial savings versus the reference products will also continue to increase.7

Fresenius Kabi oncology products are used in many different cancer types including:

+ Click on the image to enlarge

* 6 products at #1 market share & 6 products at #2 market share. Source: IQVIA;
** Fresenius Kabi oncology products validated against chemotherapy regimen list from National Comprehensive Cancer Network (accessed 4/2020 from nccn.org)

  1. Mariotto AB, Enewold L, Zhao JX, Zeruto CA, Yabroff KR. Medical Care Costs Associated with Cancer Survivorship in the United States. Cancer Epidemiol Biomarkers Prev. 2020;29(7):1304-12.
  2. Dieguez G, et al. https://www.milliman.com/en/insight/2017/a-multi-year-look-at-the-cost-burden-of-cancer-care. Published 2017. Accessed May 5, 2021.
  3. Lyman GH, et al. American society of clinical oncology statement: Biosimilars in oncology. J Clin Oncol. 2018;36(12):1260-1265.
  4. FDA. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars. Published 2020. Accessed May 5, 2021.
  5. FDA. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information Published 2020. Accessed March 18, 2022.
  6. Lyman GH. How biosimilars will impact costs and care in oncology. Clin Adv Hematol Oncol. 2019;17(10):544-547.
  7. Tilleul PR, et al. Introduction of biosimilar pegfilgrastim in France: Economic analysis of switching from originator [published online ahead of print 2020 Oct 6]. J Oncol Pharm Pract. 2020:1078155220962208.

Immunology Expertise

Immunology Expertise

Providing affordable and high-quality health care to patients coping with chronic diseases is an integral part of Fresenius Kabi’s purpose, and this is demonstrated by our long-term commitment toward developing a comprehensive portfolio of immunology biosimilars. Our biosimilars are produced in an established European facility with over 20 years’ experience in manufacturing biologics.1

35+

We have launched biosimilars in more than 30 countries to date

4+ Years

Our adalimumab biosimilar has been in market in many countries since 2019

Parenteral nutrition support

Gastroenterologists may also know Fresenius Kabi as the U.S. market leader of lipid injectable emulsions2

Small molecules

Our small molecule portfolio includes several agents used in the immunology space, such as dexamethasone and methotrexate*

In immunology, our pipeline includes biosimilars of adalimumab (an anti TNF alpha monoclonal antibody which is used to treat many autoimmune diseases), tocilizumab and others. In the field of biosimilars, Fresenius Kabi is continuously committed to developing new medicines in these important therapeutic areas; we have multiple candidates in various development phases, in both the autoimmune and oncology therapeutic areas.

*Full product descriptions and safety information can be found at products.fresenius-kabi.us.

  1. https://www.merckgroup.com/content/dam/web/corporate/non-images/country-specifics/switzerland/who-we-are-merckswitzerland-FR.pdf, retrieved 04/2022
  2. Data on file 4/1/22 calculation includes all ILEs approved in the U.S.

Our U.S. Presence

Our U.S. Presence

Our presence in the U.S. continues to grow. We have invested nearly $1 billion over the past few years1 in pharmaceutical manufacturing facilities in Illinois, New York and North Carolina, and in new distribution centers throughout the U.S. We delivered more than 700 million units of injectable medicine to the U.S. in 20211 and have secured additional capacity in different geographic areas to support product availability and rapid scalability to meet market needs. We continue our commitment to making affordable, high-quality health care available to more patients coping with critical and chronic diseases.
  1. 2021 Data on file

Getting affordable medicines to your patients

We are committed to putting essential medicines and technologies into the hands of people who help patients. And we will always look to find the best answers to the challenges patients face. Ultimately, we are driven by our philosophy – caring for life – and this filters into everything we do.

Our biosimilars history

2012

The biosimilars business unit was established within the biopharmaceutical development / production network of Merck KGaA.

2017

Fresenius Kabi strategically acquired the biosimilar business unit of market leader Merck KGaA, with a pipeline focusing on oncology and autoimmune disease

2019-2021

Fresenius Kabi has successfully launched biosimilars in Europe (2019), Canada (2021) and Australia (2021)

Now

We are focused on bring the benefits of oncology and immunology biosimilars to healthcare providers and patients in the U.S.

Committed to ongoing biosimilar support and guidance

Fresenius Kabi puts patients first, helping health care professionals optimize patient care through education and support programs provided to patients and families/caregivers.

Fresenius Kabi has team members in the U.S. and around the world to help physicians and patients. We provide educational support and clinical data related to Fresenius Kabi biosimilars. Through the KabiCare Patient Support Program, patients, caregivers and health care providers have access to multiple layers of support and resources throughout the treatment journey.

To learn more about KabiCare, visit our website

A female physician discussing lab results with a patient.

Fresenius Kabi at a glance

41,000

Dedicated Team Members

A global team of nearly 41,000 dedicated team members

90

R&D Centers

Operating more than 90 R&D centers and manufacturing facilities worldwide

150

Countries

Serving customers in more than 150 countries

Shaping the future of health care

Fresenius Kabi is part of a group of companies with unique depth and breadth in health care. Our parent company employs 300,000 employees worldwide and has more than $37 billion in revenue.1
Fresenius Logo
Operating Companies
Fresenius Kabi logo
Medicines and technology for infusion, transfusion, and clinical nutrition.
Fresenius Helios logo

Operation and management of hospitals and other sites of care.

Investment Companies
Fresenius Medical Care logo

Equipment and services for dialysis and renal care.

Fresenius Vamed logo

Planning, construction, and management of care facilities.

Operating Companies
Investment Companies
Fresenius Kabi logo
Medicines and technology for infusion, transfusion, and clinical nutrition.
Fresenius Helios logo

Operation and management of hospitals and other sites of care.

Fresenius Medical Care logo

Equipment and services for dialysis and renal care.

Fresenius Vamed logo

Planning, construction, and management of care facilities.

  1. Fresenius. https://www.fresenius.com/Group-Overview. Published 2021. Accessed June 1, 2021.
  2. Source: https://www.fresenius.com/financial-results