Providing you with a fully integrated approach to the development of biosimilar medicines

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.

  • 350

    Biologic studies involving 9,500 sites
  • 28,000

    Patients involved in our studies
  • 30+

    Biosimilar studies including early phanse and phase III

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The recent FDA Draft Guidance (January 2017) on Biosimilars provides greater clarity on regulatory requirements and the type of data sponsors will need to provide to demonstrate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

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.

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.


For more information, download our infographic on Biosimilars