Biosimilars


Integrated services every step of the way

The importance of biologics in today’s drug development market is evident from the numbers. As the number of biologics going off patent increases, biosimilar medicines, can be a competitive offering and a more cost effective alternative for patients everywhere.

However biosimilars are relatively new to certain markets,and the number of approved durgs in the US is low.  As the reuglatory environment evolves and matures, the uptake of development in this area is increasing. You need the support to choose the right target molecule, the optimal development and commercial strategy.

ICON provides clients with a fully integrated approach to the development of biosimilar medicines. We have the insight in drug development, regulatory and commercialisation combined with the operational capability to deliver your programmes on time and within budget. Specialist consultants will be with you every step of the process; from the selection of the target biologic, through the characterisation of the structure, process scale-up and function of the molecule to approval and beyond.

Services in Biosimilars:

  • Scientific Affairs, Analytics and Consulting
  • Pre-clinical / Phase I
  • Project Management and Clinical Development
  • Bioanalytical laboratory
  • Commercialisation Strategy Support

ICON is experienced in providing clinical development and commercial strategies for large, complex molecules.

Experience in Biologics and Biosimilars

479 Biological studies, >8000 Global sites, >25000 Patients, 30+ Studies with Biosimilar Products covering early phase and phase III


 

Integrated Biosimilar Services