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LOCATIONS

We work on a global scale in many countries around the world.

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POWER BY MULTIPLICITY

An alliance of 5 specialized partners, each with its solid core competence, form one unique team to develop your biosimilar.

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The Biosimilars Group - Facts & Figures

FACTS & FIGURES

We have a track record in biosimilars development.

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LOCATIONS

We work on a global scale in many countries around the world.

LOCATIONS: Bulgaria, Brazil, China, Denmark, Germany, Hungary, India, Jordan, Norway, Poland, Romania, Russia, Serbia, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States of America.

Power by multiplicity

An alliance of 5 specialized partners, each with its solid core competence, form one unique team to develop your biosimilar.

Quality target definition and monitoring of Reference Molecule

Quality driven biosimilar development

Demonstration of biosimilarity

Stability and release testing

Development of high titer production cell lines

Master / Working Cell Bank generation

Upstream and downstream process development

GMP production and analytics for clinical and market supply

Non-clinical assessment of biosimilarity

Non-clinical safety and efficacy testing

Targeted intelligent testing

Full service for phase 1-4 studies from protocol to report

Pharmacokinetic trials in healthy subjects and patients

Immunogenicity studies

Therapeutic equivalence trials

Broad therapeutic spectrum

Global regulatory development strategies for biosimilars

All types of health authority submissions

Pharmacovigilance services

FACTS & FIGURES

Track record in biosimilars development

  • 250 successful projects across all functions in the last 5 years
  • 750 highly qualified professionals in the group
  • 75 Mio EUR revenues in the group
  • 12 years of experience with biosimilars development
  • Regular successful submissions at EMA and FDA
  • Working for customers worldwide

solutions tailored to your specific requirements

The Biosimilars Group is covering all aspects of biosimilars development from candidate identification to marketed product.