Biosimilars

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.

Evolving regulatory environment 

FDA Draft Guidance (January 2017) on Biosimilars provides greater clarity on regulatory requirements and the type of data sponsors will need to provide to demonstrate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.

Integrated services

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.

• Drug Development Consulting: We have a strong track record in strategically advising clients through the development continuum.
• Early Phase Services & Clinical Pharmacology: ICON specialises in the strategy and delivery of early-phase clinical development services to enable informed, timely decision making for our clients.
• Phase III Clinical Research Services: We provide clients with a flexible, best-in-class approach to improve cycle times, constrain costs and reduce risks. 
• Bioanalytical Laboratories: ICON provides a full range of laboratory services that are dedicated exclusively to clinical development. 
• Regulatory Affairs: We are committed to delivering superior quality regulatory services that enable our clients to expedite drug development programmes. 
• Real World Intelligence: ICON delivers operational and consulting services to achieve product authorisation, through the strategic design and delivery of real world evidence studies and late phase research.
• Value Access and Outcomes: Integrated market access, pricing, communications and health economics experts provide strategic guidance and tactical solutions to demonstrate the value of your product and support brand success around the globe.