Quality in biosimilars built into every step
Quality is built into every stage of the biosimilar journey – from development and manufacturing to distribution and patient care.
Understanding Biosimilars
Biologic medicines are made using living cells and are often used to treat a wide range of diseases, such as autoimmune disorders, cancer and rare diseases. Biosimilars help expand access to these important treatments by meeting rigorous regulatory standards and demonstrating no clinically meaningful differences in quality, safety or efficacy compared with the reference biologic. Before approval, biosimilars undergo extensive scientific evaluation and regulatory review.
A simple introduction to biosimilars and how they compare with reference biologic medicines.
Go inside the development and manufacturing journey - from cell line development and testing to quality control, regulatory review and supply.
Learn how a monoclonal antibody, a type of biologic medicine, can interact with specific targets in the body and why they are used in the treatment of a wide range of diseases.
Our global biosimilars footprint built for quality, scale and access
Our Biopharma business combines Fresenius Kabi's global commercial reach with mAbxience's biologics development and manufacturing expertise to support the development, scale and reliable supply of biosimilars. Spanning Europe, Latin America and the United States, this integrated platform supports the end-to-end development, manufacture and supply of biosimilars – helping expand access to high-quality biologic medicines for patients worldwide.
Bad Homburg, Germany
Global leadership and strategic hub for Fresenius and Fresenius Kabi. Home to key Biopharma leadership and corporate functions supporting strategy, governance and business operations across the global organization.
Eysins, Switzerland
Global Biopharma R&D and commercial hub. Home to our biosimilars development organization, spanning analytical sciences, product development, clinical development, regulatory affairs and device development.
León, Spain
A flexible biologics site within the mAbxience network, supporting R&D, process development, small-scale manufacturing and pilot production capabilities.
Munro, Argentina
A biologics development and manufacturing site within the mAbxience network, supporting GMP production from clinical to commercial-scale needs.
Garín, Argentina
A biologics manufacturing site within the mAbxience network, supporting large-scale manufacturing and global supply capabilities.
Lake Zurich, US
US commercial hub supporting market access, customer engagement and the delivery of biosimilars to healthcare providers, payers and patients across the United States.
1. Scientific rigor by design: Quality begins long before a medicine reaches patients.
Extensive analytical, functional and clinical evidence is used to demonstrate biosimilarity and reduce uncertainty early in development. Through disciplined execution, strong governance and science-based decision-making, quality is built in from the very beginning.
2. Controlled manufacturing excellence: Protecting quality through every stage of production.
Biologic medicines require highly controlled manufacturing processes. From sterile manufacturing and environmental monitoring to packaging, analytics and product release, rigorous controls help ensure consistency, reliability and product integrity. Over 60 analytical and quality control tests support every batch before release.
3. End-to-end quality management: Quality is protected across the entire value chain.
Our integrated approach connects R&D, manufacturing, quality, regulatory affairs and supply chain teams into a single quality system. This helps ensure quality, consistency and traceability from development through to patient delivery.
4. Global traceability and reliable supply: Quality is only delivered when medicines reach patients as intended.
Our global network supports full traceability, monitoring and control across storage, transportation and distribution. This helps maintain product integrity and supports reliable supply for healthcare systems around the world.
5. A culture built around patients: Quality starts with people.
Quality is not only about systems and processes - it is embedded in the decisions, behaviours and accountability of our people. Through a culture of transparency, continuous improvement and patient focus, quality becomes a shared responsibility across the organization.
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FAQ
A biosimilar is a biologic medicine that is highly similar to an already approved biologic medicine, known as the reference medicine. Biosimilars must show no clinically meaningful differences in quality, safety and efficacy compared with the reference medicine.
No. Generic medicines are copies of small-molecule medicines made through chemical synthesis. Biosimilars are developed from living cells and are highly similar to complex biologic medicines, which means they require a different development and regulatory review process.
Biosimilars are reviewed by regulatory authorities before they can be approved. Approval is based on evidence showing that the biosimilar is highly similar to the reference medicine and has no clinically meaningful differences in quality, safety and efficacy.
Biosimilars can help expand access to biologic medicines, making care available to a larger number of patients to support more sustainable healthcare systems. They may create opportunities for savings that can be reinvested in patient care, innovation and healthcare system capacity.
Approved biosimilars must meet strict regulatory standards for quality, safety and efficacy. Regulatory authorities require evidence that there are no clinically meaningful differences compared with the reference biologic medicine.
Information about prescription medicines is governed by local regulations. In some countries, patients and healthcare professionals can visit local Fresenius Kabi websites for product information; in others, only limited information may be available. Patients should always seek advice from a healthcare professional.
If patients experience side effects, they should speak to their doctor, pharmacist or nurse. Possible side effects can also be reported to Fresenius Kabi through the relevant side-effect reporting route, and in the UK through the Yellow Card Scheme.