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 drugs in the US is still low.  As the regulatory environment evolves and matures, the uptake of development in this area is increasing. 

ICON provides clients with a fully integrated approach to the development of biosimilar medicines. We can help you to choose the right target molecule and the optimal development and commercial strategy.  Our experts have the insight needed in drug development, regulatory conditions and commercialisation along with the operational capability to deliver your programmes on time and within budget.

Specialist consultants will be with you every stage of the process; from the selection of the target biologic, the characterisation of the structure, process scale-up and function of the molecule through to approval and beyond.

Integrated Services in Biosimilars:

  • Drug Development Consulting
  • Early Phase Services  & Clinical Pharmacology
  • Clinical Research Service
  • Bioanalytical laboratories
  • Regulatory
  • Commercialisation & Outcomes

ICON is also 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