Biopharma

Expanding access to biologic medicines through biosimilars

Biopharma is Fresenius’ global biopharmaceutical business unit focused on the development, manufacturing and supply of biosimilars – biologic medicines that are highly similar to approved reference biologics in quality, safety and efficacy – to help expand access to advanced treatments for patients worldwide.

Person wearing protective eyewear and a lab coat working beside laboratory equipment and a digital interface.

As demand for biologic medicines grows, healthcare systems are facing increasing pressure to meet the needs of people living with chronic and complex diseases. 

Combining scientific expertise, integrated development and manufacturing capabilities, and global supply reach, our Biopharma teams help expand access to biologic medicines through biosimilars, supporting the long-term sustainability of healthcare systems worldwide.

Our ambition is to be a leading global biosimilars company, helping expand access to biologic medicines through a growing portfolio, integrated capabilities and global reach.


Two people in cleanroom clothing and protective eyewear working with laboratory equipment and a glass container.

8x
increase in patient impact potential

The next decade is expected to expand access to biologic medicines on a scale not previously seen.1

100+ 
biologic medicines losing exclusivity
by 2030

An unprecedented wave of biologic patent expiries is creating new opportunities for biosimilar development and patient access.1

>$100bn
projected healthcare savings in EU and US
by 2030

Biosimilars are expected to generate substantial savings that can be reinvested to support patient care, innovation and healthcare system sustainability.2

Meeting growing demand for biologic medicines 

Demand for biologic medicines is rising as more people live with chronic and complex diseases. At the same time, an unprecedented wave of biologic medicines losing exclusivity is creating new opportunities to expand access for millions more patients. In Biopharma, we are helping expand access to biologic medicines through four priorities: innovation focused on patient needs, ensuring quality and resilient supply, supporting future-ready healthcare systems, and empowering people and partnerships.

Innovation focused on patient needs

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We focus on biosimilars in areas where expanded access to biologic medicines can make a meaningful difference for patients and healthcare systems.

  • 11 marketed products and 18 clinical-stage assets across major areas of healthcare need.
  • Ambition to double our pipeline and support more than 1 billion patient treatment days by 2030. 

  • Patient and healthcare professional insights help guide development and support programs.

Ensuring quality and resilient supply

Material-handling equipment moving a pallet between tall warehouse racks filled with cardboard boxes.

Our integrated value chain supports quality, supply resilience and the ability to scale globally.

  • Integrated R&D, manufacturing and commercial capabilities have reduced end-to-end lead times by 33% over the past five years.
  • Rigorous scientific evidence and manufacturing controls help safeguard product quality from development through to release. 

  • Global infrastructure spanning more than 100 countries helps ensure reliable access to biosimilars worldwide.

Supporting future-ready healthcare systems

Two clinical staff members reviewing information together on a computer monitor at a workstation.

We work with stakeholders across healthcare to support sustainable access, science-led policy environments and the long-term resilience of healthcare systems.

  • Targeting over 60% of biologics expected to lose exclusivity in the coming years.

  • Projected to support more than 1 billion patient treatment days by 2030. 

  • Working to contribute more than €35 billion in cumulative healthcare savings across the EU and US alone by 2030.

Empowering people and partnerships

Two people in cleanroom protective clothing working with stainless-steel processing equipment.

Expanding access takes collaboration. We work across healthcare - with partners, healthcare professionals (HCPs), patient communities, policymakers and our own teams - to help biosimilars reach more people, responsibly.

  • Top Employer 2026 across 13 countries, bringing together expertise across R&D, manufacturing, medical, commercial and regulatory functions.

  • Strategic partnerships strengthen scientific, manufacturing and commercial capabilities worldwide. 

  • FRAME supports scientific exchange and collaboration with healthcare professionals. 

  • Patient engagement initiatives help ensure patient perspectives inform our work.


What is a biosimilar - and why are they so important?

A biosimilar is a biologic medicine that is highly similar to an already approved biologic medicine, known as the reference medicine. Biosimilars must meet rigorous regulatory standards and demonstrate no clinically meaningful differences in quality, safety and efficacy compared with the reference medicine.

Pink reference and blue biosimilar Y-shaped molecular structures shown side by side.

Meet some of our Biopharma leaders

Our Biopharma team brings together expertise across science, development, manufacturing, commercialization, medical affairs, patient support and partnerships – united by a shared commitment to expand access to high-quality biosimilars worldwide. 

References:

1. Assessing the Biosimilar Void. IQVIA Report (2023). Available at: https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/assessing-the-biosimilar-void  [Last accessed: July 2026]

2. 'Meet the Management' © Fresenius SE & Co. KGaA Investor Relations (2025). Available at: Biopharma 'Meet the Management' [Last accessed: July 2026]