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Biosimilars

Deep expertise you can rely on

As the number of biologics going off-patent increases and the 'patent cliff' approaches, more and more biosimilar developers are looking to reap the benefits, driven by governments, healthcare organisations, physicians and patients seeking greater choice and a more cost-effective alternative to reference drugs.

ICON's Biosimilar expertise

ICON has decades of experience supporting biosimilar development, including some of the earliest biosimilars to receive global approval. In addition to the design and execution of clinical trials, ICON has deep biosimilar subject matter expertise in essential functions such as drug development, clinical study design, therapeutic experts, clinical pharmacology, pharmacokinetics, regulatory strategy, biostatistics and regulatory CMC.

We have participated in pivotal or supportive trials and key Biological License Application (BLA) support services. These trials led to the US Food and Drug Administration (FDA) and international regulatory approval for numerous products across therapeutic areas, including support for some of the initial biosimilars to be approved globally. In addition, we provide non-clinical services for many biosimilars projects.

  • 45+

    Biosimilar trials

  • 3,300+

    Research sites

  • 14,800+

    Patients and healthy volunteers

Over the past five years, ICON has participated in over 45 biosimilar trials in 59 countries, engaging 14,800+ patients at 3,300+ research sites. This includes 13 pivotal trials leading to market approvals across key therapeutic areas like oncology, systemic anti-infectives and immunomodulators. Our experience spans early-stage consulting through to regulatory approvals, ensuring that our clients are supported at every stage of development.

Getting your biosimilar to market faster

ICON’s ability to accelerate speed to market enables our clients to reduce development timelines, optimise costs, and maximise return on investment. By leveraging our global infrastructure, technological solutions, and deep biosimilar expertise, we streamline critical processes—from clinical trial execution to regulatory approval—helping clients bring their biosimilars to market faster and more efficiently.

High-quality data in a complex regulatory landscape

Stringent regulatory requirements guide the development of biosimilar medicines and ensure the highest standard of quality, non-clinical, and clinical comparability data. The type and extent of data needed varies depending on the complexity of the molecule, the availability of an accepted surrogate endpoint, and the seriousness of safety concerns for the reference product or substance class. We develop our biosimilars development programs on a case-by-case basis.

Integrated services

ICON provides clients with a fully integrated approach to the development of biosimilars. We can help you to choose the suitable 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. 

Our Biosimilars Team can provide the following support:

  • Design and execution of global biosimilar clinical plans, including protocol development
  • Oversight and collaboration with study teams to ensure on-time and high-quality outcomes
  • Gap analysis of [preliminary] comparative analytical similarity assessment (e.g., structural and functional data)
  • Supplemental resources on your development team to execute and oversee programmes
  • Drug Development Consulting and strategic advice throughout the development continuum
  • Strategy and delivery of early-phase clinical development for informed, timely decision making
  • Clinical pharmacology expertise and support for pharmacokinetic analyses
  • Phase 3 Clinical Research Services, for a flexible, best-in-class approach to improve cycle times, constrain costs and reduce risks
  • A full range of bioanalytical laboratory services that are dedicated exclusively to clinical development
  • Superior quality regulatory services to expedite drug development programmes
  • Operational and consulting services to achieve product authorisation, through the strategic design and delivery of real-world evidence studies and late phase research
  • Commercialisation and integrated market access, pricing, communications and health economics experts, strategies and tactics to demonstrate the value of your product and support brand success around the globe
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