ICON can support product design, development and registration, regulatory support and commercialisation.


The successful development and commercialisation of biosimilars programmes requires a deep understanding of the complexities of the biologics landscape. Our integrated clinical, regulatory and commercial expertise provide a cohesive framework to overcome challenges and deliver effective biosimilar strategies.

Our dedicated cross-functional biosimilars group comprises highly skilled experts with diverse backgrounds on both the originator and clinical research side. In addition to dozens of licensed biopharmaceutical products, we have extensive on-going experience conducting biosimilar trials which enable us to deliver compressed timelines and proactive risk mitigation:

  • 160 studies
  • 25,000 patients
  • 8,100 sites

Integrated Biosimilars Services

Explore ICON’s clinical and non-clinical services supporting biosimilars studies:

Development Strategy Consulting

Commercial and Marketing Services

Product Development Capabilities

Regulatory Support Services