New product and process development and the improvement of therapies are at the core of our strategy. Research and development activities mainly take place in the Fresenius Kabi business segment. We focus our R & D efforts on our core competencies in the following areas:

• Generic IV drugs
• Biopharmaceuticals
• Infusion and nutrition therapies
• Medical devices

Apart from new products, we are concentrating on developing optimized or completely new therapies, treatment methods, and services.

Research services provided by third parties are mainly used by Fresenius Kabi, especially in the field of biopharmaceuticals.

As of December 31, 2023, there were 2,522 employees in research and development (2022: 2,564).

Our main research sites are in Europe, the United States, and India. Product-related development activities are also carried out in China.

Group Research and development expenses^1,2 were €607 million (2022: €631 million) in the fiscal year. Research and development expenses^1,2 at Fresenius Kabi accounted for 7.6% of Fresenius Kabi total revenue (2022: 8.0%).

Fresenius Kabi

Fresenius Kabi's research and development activities concentrate on products for the therapy and care of critically and chronically ill patients. Our products are used where the patient is most at risk: in emergency medicine, intensive care, special care, and for those who need to be treated in hospital or as an outpatient for a longer period of time. In these patient groups, every single step is essential for the success of the therapy. Products of Fresenius Kabi make a crucial contribution to the success of the treatment and the interaction between medicine and technology is highly important.

We consider it our task to develop products that help to support medical advancements in acute and post-acute care and improve patients quality of life. At the same time, our products are intended to enable an increasing number of people worldwide to have access to high-quality, modern therapies.

Chronic diseases are on the increase worldwide; more and more people need access to high-quality therapies. In the care of critically ill patients, the requirements for successful treatment are becoming ever higher. The demand for effective therapies in conjunction with intelligent medical technology applications and devices will continue to rise in the future. We want to be the preferred point of contact for doctors and nursing staff in the care of critically and chronically ill patients.

With our Vision 2026 we have defined a clear direction for Fresenius Kabi with three growth areas: the broadening of our biopharmaceutical range, the further development and global introduction of our clinical nutrition products, and expansion in the area of MedTech. In the volume-driven IV business, we will continue to expand our resilience. Our future development work will be geared toward this.

Our development expertise includes all related components, such as the drug-active pharmaceutical ingredients and raw materials, the pharmaceutical formulation, the primary packaging, the medical device needed for application of drugs and infusions, and the production technology.

In the biopharmaceutical area, our currently expanding and highly attractive product pipeline of biosimilarsBiosimilarsA ​biosimilar ​is ​a ​drug ​that ​is ​“similar” ​to ​another ​biologic ​drug ​already ​approved. includes a range of commercialized medicines and molecules in various development stages. Predominantly targeting areas of immunology and oncology, we are committed to providing access to biologics for more patients and healthcare providers around the world. Our high-quality, effective, and safe therapies offer solutions for patients and healthcare professionals and contribute significantly to the care and quality of life of patients.

With the 55% majority stake acquisition in mAbxience in 2022, we diversified our biosimilars pipeline, vertically expanded our research & development and manufacturing capabilities, and extended our B2B contract development and manufacturing (CDMO) business offering. With a proven track record in delivering high-value biologic projects, our partners can benefit from our specialized services for the biosimilar development and manufacturing of biopharmaceuticals and complex proteins offered by our CDMO business.

Our experience spans many years in the research & development of biopharmaceuticals. We have a research & development center for biosimilars in Eysins, Switzerland, where new biosimilars for the treatment of autoimmune and oncological diseases are developed in state-of-the-art development and research laboratories. The state-of-the art mAbxience GMP (Good Manufacturing Practice) research & development laboratories are based in Europe (Léon, Spain) and South America (Garín and Munro, Argentina). Our R & D centers with cutting-edge technology include small-scale facilities and pilot plants focused on process optimization, clinical batches and new technologies.

A biosimilar is a biological product that is similar to another approved biological product called the reference product. The biosimilar product demonstrates a similar analytical profile, similar pharmacokinetic and comparable efficacy, safety, and immunogenicityImmunogenicityThe ​ability ​of ​an ​antigen ​to ​cause ​an ​immune ​response ​(immunization, ​sensitization). to the reference product. We apply the same high-quality standards to our biosimilar products throughout the entire value chain, from research, development, and manufacturing to commercialization, as are required for the reference product. The adoption and uptake of biosimilars has been growing considerably worldwide and more and more patients are being treated with high-quality biologic drugs.

Our first biosimilar Idacio^®1, an adalimumab biosimilar that can be used in chronic inflammatory diseases such as rheumatoid arthritis, Crohn's disease, or psoriasis (skin disease), has been approved and commercialized in over 39 countries since its introduction in 2019. In July of the reporting year, IDACIO^® was launched in the United States, as well as in Paraguay and Latvia. We will continue to work toward providing access to more patients in additional markets globally.

Our second biosimilar, Stimufend^®2, a pegfilgrastim biosimilar used to treat patients who experience neutropenia following chemotherapy, was launched in the United States in February 2023 following approval from the U.S. Food and Drug Administration (FDA) in September 2022. Stimufend^® was already launched in France in the last quarter of 2022.

Our third biosimilar, Tyenne^®3, was launched in the European Union (EU) in November 2023 and is the first tocilizumab biosimilar to receive approval and be made available in the EU. Commercial activities for Tyenne^® have been ongoing in six European countries since November 2023. Tyenne^® is a biosimilar to the reference medicinal product RoActemra^®4, a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. Tocilizumab is a biological therapy approved in the EU for use in the treatment of various inflammatory and immune-mediated conditions, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome (CRS), as well as for the treatment of COVID-19.

In August 2022, the FDA accepted for review Fresenius Kabi's 351(k) Biologics License Application (BLA) for its tocilizumab biosimilar candidate for both intravenous and subcutaneous administrations (prefilled syringe and autoinjector), Fresenius Kabi's third BLA submission to the FDA. The Tyenne BLA was supplemented in September 2023 after the U.S. FDAs inspection findings at the manufacturing site had been fully addressed. No issues were identified with the biosimilarity, preclinical, or clinical trial results that were submitted in the dossier for the first time.

In July 2023, Fresenius Kabi announced that its denosumab biosimilar candidate FKS518 successfully met its primary and secondary objectives in a recently conducted clinical trial on pharmacokinetic similarity. The randomized, double-blind, parallel-group study compared the pharmacokineticsPharmacokineticsThe ​effect ​of ​the ​body ​on ​the ​drug., pharmacodynamics, safety, tolerability, and immunogenicity of FKS518 to the U.S. reference product Prolia^®5 following a single subcutaneous injectionSubcutaneous injectionAn ​injection ​of ​vaccines ​or ​drugs ​into ​the ​subcutaneous ​fat ​tissue. in healthy male subjects. The study also successfully demonstrated pharmacokinetic equivalence of FKS518 to the U.S. reference product Prolia^®. The pharmacodynamic responses evaluated by quantification of bone turnover biomarkers, as well as safety and immunogenicity data, support biosimilarity of FKS518 to the U.S. reference product.

The company is also conducting a clinical study with the aim of comparing the efficacy, safety, tolerability, and immunogenicity of its denosumab biosimilar candidate FKS518 with the U.S. reference product in postmenopausal women with osteoporosis.

In the reporting year, Fresenius Kabi and its license partner Formycon secured the U.S. license date for the proposed ustekinumab biosimilar candidate to Stelara^®6, FYB202, a proposed ustekinumab biosimilar. As per the settlement agreement, Fresenius Kabi and Formycon have the right to market FYB202 in the United States from no later than April 15, 2025.

In September 2023, Fresenius Kabi and its license partner Formycon also announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for FYB202.

In November 2023, Fresenius Kabi and its license partner Formycon announced the FDA submission acceptance for review for the ustekinumab biosimilar candidate FYB202.

In addition to Fresenius Kabi's biosimilars development activities in Switzerland, mAbxience develops biosimilar products in Spain and Argentina. Bevacizumab and rituximab, two of mAbxience's biosimilars used to treat various types of cancer, have been commercially available to patients in more than 40 countries in Latin America, Asia-Pacific, and the Middle East for many years. In addition, mAbxience received EMA approval for its bevacizumab biosimilar in 2021, making it available in Europe.

In the United States, the FDA granted marketing approval for mAbxience's bevacizumab biosimilar, making it available to patients in the United States as of October 2022.

Furthermore, mAbxience received marketing approval for the bevacizumab biosimilar in seven additional countries between August and December 2022, and in two countries in the reporting period.

In the reporting year, mAbxience announced a strategic partnership with Abbott to commercialize several biosimilars focusing on oncology, womens health, and respiratory diseases in emerging markets including Latin America, Southeast Asia, the Middle East, and Africa.

In October 2023, mAbxience also announced an exclusive licensing agreement with Amneal Pharmaceuticals to commercialize the mAbxience denosumab biosimilars for the treatment of oncology and bone diseases in the U.S. market.

Furthermore, mAbxience announced an exclusive licensing agreement with MS Pharma to commercialize the denosumab biosimilar in selected markets in the Middle East and Africa. Under the terms of the agreement, mAbxience will conduct the full development of the biosimilar and manufacture it in its state-of-the-art, GMP-approved facilities.

In November 2023, mAbxience and Abdi İbrahim, the leading pharmaceutical company in Türkiye, announced a technology transfer agreement. This collaboration marks a historic milestone in the production of biopharmaceuticals in Türkiye, specifically focusing on a crucial cancer drug.

Fresenius Kabi is a leading provider of clinical nutrition products as well as related medical-technical products and disposables for administering these products. Clinical nutrition provides care for patients who cannot nourish themselves normally or sufficiently. This includes, for example, patients in intensive care and those who are seriously or chronically ill.

There are two types of clinical nutrition therapy: parenteral nutritionParenteral nutritionApplication ​of ​nutrients ​directly ​into ​the ​bloodstream ​of ​the ​patient ​(intravenously). ​This ​is ​necessary ​if ​the ​condition ​of ​a ​patient ​does ​not ​allow ​them ​to ​absorb ​and ​metabolize ​essential ​nutrients ​orally ​or ​as ​sip ​and ​tube ​feed ​in ​a ​sufficient ​quantity. and enteral nutritionEnteral nutritionApplication ​of ​liquid ​nutrition ​as ​a ​tube ​or ​sip ​feed ​via ​the ​gastrointestinal ​tract.. Parenteral nutrition is administered intravenously when the intestinal function is impaired. This is necessary if the condition of a patient does not allow them to absorb and metabolize essential nutrients orally or as sip and tube feed in a sufficient quantity. Enteral nutrition is administered in the form of a sip or tube feed using the gastrointestinal tract. Fresenius Kabi is one of the few companies worldwide to offer both forms of clinical nutrition.

Clinical nutrition provides care for patients who cannot nourish themselves normally or sufficiently. This includes, for example, patients in intensive care units (ICU) and those who are critically or chronically ill. Early and adequate intervention can help prevent malnutrition and its consequences.

Malnutrition is a common problem in hospitalized patients: studies carried out in Europe show that one in four patients in the hospital suffers from malnutrition or is at risk of malnutrition. The clinical significance of malnutrition results from a less favorable prognosis in terms of morbidity and mortality. Further consequences can be a longer stay in the hospital and higher associated treatment costs.

In the parenteral nutrition product segment, we focus our research and development on products that help improve clinical treatment and the nutritional condition of patients, as well as on innovative containers such as our multi-chamber bags that are safer and more convenient in everyday use, both in a hospital and in a homecare setting.

In 2023, we continued our development work on parenteral nutrition products. We are concentrating on formulations that are tailored to the needs of individual patient groups. In addition to our global development projects, we work on parenteral nutrition products for specific markets and regions such as the United States, China, and Europe.

The use of fish oil in parenteral nutrition continues to be a focus area. Parenteral nutrition containing fish oil has numerous beneficial effects on important biological functions, including the modulation of the immune and inflammatory response. The use of fish oil in parenteral nutrition products may help to improve clinical outcomes and shorten ICU and hospital length of stay.

In the area of enteral nutrition, we are focusing our research and development activities on product concepts that support therapeutic compliance and thus the success of therapy. In particular, the flavor of enteral products is known to be a critical parameter in ensuring the acceptance of the products and compliance with the nutritional therapy.

For years, we have been working continuously to develop products with a wide variety of flavors to offer the users variations and thus provide them with the best possible support to complete the necessary nutritional therapy. With the launch of the Fresubin plant-based drink, we have expanded our range of plant-based products as a response to customers demands and preference. Another focus of our work is on the development of products with an increased calorie and protein concentration. This way, we make it easier for the user to take in the necessary amount of nutrients in small volumes. In addition to global product developments, we are continuing to work on product developments for specific market requirements.

Medical devices are used for the administration of pharmaceuticals and include infusion and nutrition pumps, infusion management systems, anesthesia monitoring, as well as disposables, including infusion sets, extension lines, enteral nutrition tubes, and monitoring electrodes. A specific range of these products is designed for pediatric use. In the area of medical devices, we focus on developing new products as well as on further developing our existing portfolio. This industry in particular is characterized by technological innovations. Digitalization is a more crucial factor here than in any of our other product segments. Devices not only have to be continuously developed in terms of their application, but they also have to increasingly be embedded in the IT system landscape of hospitals, blood donation centers, and plasma centers. In the future, we want to benefit from this trend and are already focusing on the continuous development of our software solutions to increase efficiency and benefit for our customers.

As part of Fresenius Kabi's acquisition of Ivenix, a specialized infusion therapy company, Fresenius Kabi's research and development activities focus on further developing the infusion management systems (IMS) and their software, in particular regarding cybersecurity, workflow optimization, and connectivity with various electronic medical record (EMR) systems.

We also continued the development work on our new infusion management system Exelia in the reporting year. This system features a modern operating system and will enable new therapy and treatment procedures in the intensive care unit and operating room. Fresenius Kabi will continue to develop the Exelia system further to continuously meet the advancing demands in the area of application.

In the reporting year, we continued to develop the Vigilant Software Suite, a software solution for our Agilia family of infusion pumps in hospitals.

In research and development in the area of transfusion technology, we are working intensively on products for use in cell therapy. Our focus is on product developments for the automated washing and concentration of cell concentrates. These products are used in CAR T-cellCAR T cell therapyIn ​this ​therapy ​form, ​the ​immune ​cells ​of ​patients ​are ​collected, ​genetically ​modified, ​and ​reinfused ​into ​the ​patient ​with ​better ​characteristics ​than ​before. ​In ​the ​patient’s ​body, ​they ​activate ​the ​immune ​system ​and ​destroy ​cancer ​cells. and similar cell therapies. In 2023, we worked on software enhancements for our cell therapy products LOVO¹ and CUE¹. In the area of our plasma donation product Aurora Xi, we are working on a software solution and the associated clinical study to further increase the plasma yield and efficiency per donor.

In the area of extracorporeal photopheresis (ECP), we continue to focus on the introduction of the Amicus Blue system and the associated Phelix light box in Europe, as well as on the further development of an ECP application method, which only requires one vascular access. In this therapy method, certain blood cells outside the body are treated with ultraviolet light (phototherapy). This method is used to treat various immunological diseases, including to kill malignant immune cells (lymphocytes) outside the body.

Fresenius Kabi offers a broad range of intravenously administered generic drugs across a wide array of therapeutic categories: oncology drugs, anesthetics & analgesics, anti-infectives, and critical-care drugs. Fresenius Kabi provides the related devices for the administration of these products. The portfolio is geared towards the treatment of and care for chronically and critically ill patients. Fresenius Kabi has a global network of production centers. Fresenius Kabi manufactures finished medicines in its own plants and, at some sites, also produces active pharmaceutical ingredients (API). Fresenius Kabi's investments aim, among other things, to continuously modernize and automate the production processes at its plants.

In the area of generic IV drugs, we are continuously working on the extension of our product portfolio. For example, in the reporting year, we launched the drug Zinc Sulfate for which one of the stock-keeping units was granted CGT (Competitive Generic Therapy) designation. Furthermore, we launched the cardiovascular drug Vasopressin in single dose vials. In Europe, we brought Sugammadex (reversal agent for neuromuscular block) onto the market on day one after patent expiry.

In addition, we are working on the continuous improvement of IV drugs already on the market. For example, we are developing IV drugs with new formulations and dosage forms, as well as improved primary packaging. In 2023, we had more than 100 active generic drug projects. Our research & development activities focus on complex formulations, such as an emulsion solution that has already been confirmed as a first-to-file abbreviated new drug application (ANDA) submission in the United States, as well as peptide formulations that can be applied with an autoinjector, among others. In addition, we are constantly working on product improvements that bring additional benefits to both medical personnel and patients. For example, we develop ready-to-use products that are especially convenient and safe and help to prevent application errors in day-to-day medical care. These include ready-to-use solutions in our freeflex infusion bags, the cost-effective KabiPac infusion bottle, and pre-filled syringes. Drugs in pre-filled syringes are easier and safer to use than traditional applications. In the reporting year, we launched Diazepam and Fentanyl in pre-filled syringes in the United States. In Europe, we launched, among others, Ondansetron, an antiemenic drug, as a ready-to-use solution in KabiPac.

To improve drug safety, Fresenius Kabi is implementing a global program to introduce data matrix barcodes on our generic drugs. This initiative is intended to prevent errors in the manual entry of drug information in data management systems, e.g., of hospitals.

Within infusion solutions, Fresenius Kabi offers products for fluid and blood volume replacement. Moreover, Fresenius Kabi's product portfolio includes a broad range of infusion technologies as well as disposables for the delivery of medication for all pharmaceuticals administered via the vein.

Fresenius Kabi provides a wide range of infusion therapy products, including the following: basic infusion solutions, which consist primarily of salts (electrolytes), carbohydrates, and water. They are infused when the body water content or electrolyte balance is impaired, as well as in acute need of energy supply and a lack of salt or specific minerals. They also serve as carrier solutions for intravenously administered drugs. In addition, Fresenius Kabi offers a comprehensive range of products in infusion bags and bottles, such as freeflex PVC-free infusion bags and KabiPac plastic bottles.

Furthermore, Fresenius Kabi manufactures blood volume substitution solutions that include hydroxyethyl starch derived from waxy maize. Artificial blood volume replacement products (colloids) are often used to treat patients suffering from hemodynamic instability due to acute blood losses, e.g., resulting from an accident or during surgery.

Fresenius Kabi also provides medical-technical equipment and disposables, such as cannulas, tubes, and pumps for administering infusion solutions.

In the area of infusion solutions, as in past years, we have focused our development activities on improving and developing new container technologies to improve the daily work routine and safety of healthcare professionals. Our portfolio extension to the U.S. market is advancing, as we are in the last stages of preparing the introduction of our product offering for infusion solutions, which was specifically designed for this key market.