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Biosimilars

Deep expertise you can rely on

As the number of biologics going off-patent rises and the ‘patent cliff’ approaches, biosimilar medicines offer healthcare organisations, physicians and patients more cost-effective alternatives with greater therapeutic choice. At ICON, we leverage our extensive experience in biosimilar development to help our clients navigate this complex and widely expanding regulated field.

What is a biosimilar?

Biosimilars are complex molecules that are highly comparable to their reference biologics, although they can never be identical to the commercially available originator. These compounds are up to 1,000 times the size of small-molecule drugs and since they are derived from living cell lines, cannot be exactly replicated. Hence, the development and manufacturing of biosimilars, through complex processes like DNA modification, gene expression and other antibody methods, are more intricate than conventional generics’ methods. In biosimilar nonclinical studies and clinical studies, the goal is not to show superiority or even non-inferiority but to prove equivalence.

ICON designs and manages these clinical trials specifically to demonstrate that your biosimilar product closely mirrors the originator for safety, efficacy, pharmacokinetic and pharmacodynamic outcomes. Learn more.

ICON’s long-standing biosimilar expertise

ICON has been at the forefront of biosimilar development for over 20 years, supporting some of the earliest biosimilars to receive global approval. We offer deep subject matter expertise across essential functions such as drug development, clinical trial design, therapeutic expertise, clinical pharmacology, pharmacokinetics, regulatory strategy, and biostatistics.

  • 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.

Challenges in biosimilar development

The biosimilars landscape presents unique challenges, from competition between developers working on the same asset, to navigating inconsistent regulatory pathways across different geographies. ICON’s experience positions us to overcome obstacles such as:

  • Complex regulatory pathways: Biosimilars face stringent regulatory requirements, which vary across regions. Our regulatory affairs experts provide the strategic insight to navigate these complexities
  • Clinical trial access: Access to clinical trial sites poses a significant challenge in biosimilar development, as finding qualified sites with experience in biosimilar studies-and ensuring patient enrolment within tight timelines is crucial for meeting regulatory and market demands efficiently
  • Clinical trial feasibility: ICON ensures robust trial design and site selection strategies to overcome challenges like patient recruitment, sourcing of reference biologics and country-specific post-trial commitments
  • Global logistics: Managing import taxes, clinical material supply and regulatory approvals across global markets
  • CMC processes: Ensuring that manufacturing and comparability processes closely match the originator product's chemistry, manufacturing and controls (CMC)

ICON’s comprehensive biosimilar services

We provide clients with a fully integrated approach to biosimilar development, from strategy to execution, tailored to the complexities of each project. Our global reach and technology-enabled solutions, such as Symphony Health (data), OneSearch (optimum site identification), Cassandra (AI for post-marketing studies probability), and FIRECREST (site/ patient engagement portal), allow us to streamline processes, manage global trials efficiently and ensure high-quality outcomes.

Our services include:

Design and execution of global clinical plans

We develop detailed clinical strategies and protocols that meet regulatory requirements

Regulatory strategy and consulting

Our regulatory affairs team helps you navigate the complex approval processes across multiple geographies

Early-phase development expertise

We provide clinical pharmacology support, pharmacokinetic analysis, and early-phase clinical trial design to inform timely decision-making

Phase 3 clinical research

We offer flexible and best-in-class approaches to improve cycle times and reduce costs while mitigating risks

Bioanalytical laboratory services

Dedicated to clinical development, our bioanalytical labs support testing methodology, ensuring high-quality comparability data

Market access and health economics

Our market access experts design commercialisation strategies to demonstrate product value, enhance market entry and support brand success globally

What makes ICON unique?

We understand the complexity of the country specific requirements and have experience in navigating the pathway through.

Expertise you need

With a team of experts spanning regulatory affairs, clinical study design and CMC, we guide you through the development continuum, mitigating risks and expediting your biosimilar’s path to market. ICON’s ability to handle large-scale global trials while offering tailored support allows us to match the needs of both large and small biosimilar developers. With access to cutting-edge technology platforms and dedicated bioanalytical labs, we ensure efficient trial management and high-quality data.

Speed-to-market

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, commercialisation experience and deep biosimilar expertise, we streamline critical processes—from clinical trial execution to regulatory strategy and approval—helping clients bring their biosimilars to market faster and more efficiently.

Experience you can trust

As the biosimilar market is projected to reach US$71 Billion by 2030, driven by the cost-effectiveness of these drugs and the growing prevalence of chronic disorders like cancer and autoimmune diseases, ICON is strategically positioned to help you embrace this opportunity. Our extensive experience, global reach and innovative solutions ensure that your biosimilar programs are delivered on time, within budget and to the highest regulatory standards.

By partnering with ICON, you not only leverage our comprehensive knowledge but also gain access to innovative, efficiency-driven strategies that make high-quality biosimilars accessible to patients sooner, maximising your competitive advantage.

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