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.
The recent FDA Draft Guidance (January 2017) on Biosimilars provides greater clarity on regulatory requirements and the type of data sponsors will need to provide to demonstrate interchangeability.
To find out more about what is contained in this first Guidance - read the blog article or view the video below.
Integrated Services in Biosimilars:
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.
ICON is also experienced in providing clinical development and commercial strategies for large, complex molecules.