350 Biologic studies: involving 9,500 sites and 28,000 patients
30+ Biosimilars studies including early phase and phase III.
The importance of biologics in today’s drug development market is evident from the statistics. As the number of biologics going off patent increases, biosimilar medicines promise to be an attractive offering to healthcare organisations, physicians and patients by providing greater choice and a more cost effective alternative.
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 biosimilars. 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:
ICON is also experienced in providing clinical development and commercial strategies for large, complex molecules.