Sustainability Hub 2023

Biosimilar development: Improving access and affordability

Biological drugs from genetically modified cell lines enable the treatment of serious diseases such as rheumatoid arthritis, psoriasis, and cancer. Fresenius Kabi is actively engaged in the development of such biosimilars. Our efforts focus on autoimmune diseases and cancer, providing patients with alternative treatment options through biological products that are similar to the reference product.

Why Biosimilars?

Chronic diseases are on the rise worldwide, and more and more people need access to high-quality therapies. However, the drawback is that these therapies are costly and therefore constitute a burden on healthcare systems. Affordable therapy options like biosimilars can help mitigate some of this financial strain.

What are Biosimilars?

A biosimilar is a biological product that is similar to another authorized biological product known as the reference product. The biosimilar product has a comparable analytical profile, with similar pharmacokinetics, and equivalent efficacy, safety, and immunogenicity to the reference product. Our biosimilar products are subject to the same high quality standards as the reference product. The authorization and acceptance of biosimilars has increased significantly worldwide, and progressively more patients are being treated with high-quality biological medicines.

In addition to the growing need for high-quality medicinal products to treat chronically ill patients, the requirements for the care of the critically ill are also increasing. This will result in a burgeoning demand for effective therapies in combination with sophisticated medical devices and technologies in the future. We strive to be the preferred partner for doctors and nursing staff in the care of both patient groups and have prioritized this mission in our business model.

Biopharmaceuticals: One of our three strategic growth areas

Our vision 2026 defines three clear areas of growth for Fresenius Kabi: enhancing our biopharmaceutical offering, advancing our clinical nutrition products, and launching them globally, and expanding in the MedTech segment.

Our focus on biosimilars: Immunology and oncology

Our growing product pipeline of biosimilars includes a number of molecules that are in various stages of development on the pathway to market maturity. Their development is focused mainly in the fields of immunology and oncology. Our work is guided by the goal of providing more patients and healthcare providers around the world with access to biologics. Fresenius Kabi’s central aim is to enable healthcare professionals to deliver high-quality, effective, and safe therapy concepts, and consequently improve patient care and quality of life.

Following the acquisition of a 55% stake in mAbxience in 2022, we have diversified our biosimilars pipeline. This move expands our research, development, and production capacities, and extends our offering as a B2B contract development and manufacturing organization (CDMO). Joining forces with our colleagues at mAbxience gives us a wealth of experience in conducting high-quality biological research and development projects for the production of biopharmaceuticals and complex molecules.

Fresenius Kabi’s research and development center at Eysins, Switzerland, has become an important location for our work on new biosimilars used in treating autoimmune and oncological diseases. mAbxience maintains research and development laboratories in Europe (Léon, Spain), and South America (Garín and Munro, Argentina). Our research and development centers also include small facilities and pilot plants focusing on process optimization, clinical batches, and new technologies.

You will find further information on our Biopharma Unit here.

200

billion

can be saved worldwide over a period of five years by using biosimilars.1

1 Source: The center for biosimilars

Lab worker holding up equipment (Photo)

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