Biologics & Biosimilars


Attractive offering to patients, physicians and payors

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 

The recent FDA Draft Guidance (January 2017) on Biosimilars provides greater clarity on regulatory requirements and the type of data sponsors will need to provide to demonstrate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 - the insight and operational capability you need

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.

At every stage of the process

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.

  • 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. 
  • Commercialisation & Outcomes
    Our expert team establishes and communicates a product's unique clinical and economic outcomes to achieve success in today's dynamic and patient-centric healthcare environment. ICON is also experienced in providing clinical development and commercial strategies for large, complex molecules.

Experience in Biologics and Biosimilars

  • 350Biologic studies involving 9,500 sites and 28,000 patients
  • 30+Biosimilar studies including early phase and phase III