ICON will be participating in ACOP 2025 in Aurora, Colorado, where we will introduce Yi Zhang, our new Scientific Director of PK in the Pharmacometrics Department. Yi brings extensive expertise in PK/PD modeling, disea...
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.
ICON has participated in pivotal studies leading to the market approval of 14 biosimilar therapies. Through our Centre for Biosimilar Drug Development, we bring together deep subject matter expertise across essential functions such as drug development, clinical trial design, therapeutic expertise, clinical pharmacology, pharmacokinetics, regulatory strategy and biostatistics.
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49
Biosimilar trials -
3,000+
Research sites -
13,400+
Patients and healthy volunteers
Over the past five years, ICON has participated in 49 biosimilar trials across key therapeutic areas including oncology, endocrinology, immunology and gastroenterology, in 59 countries, engaging 13,400+ patients and healthy volunteers at 3,000+ research sites.
Our experience spans early-stage consulting through to regulatory approvals, ensuring that our clients are supported at every stage of development.
The future of oncology biosimilars: Considerations for development through 2040
Explore the evolving oncology biosimilars landscape, regulatory strategies, challenges to market access, and innovations in post-market monitoring.
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 Centre for Biosimilar Drug Development
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.
Therapeutic insights on biosimilars
A collections of ICON's biosimilar related content, from articles to thought leadership, case studies to blogs.
Want to know more?
If you would like to know more about how we can support your biosimilar drug development or have an active project or RFP you would like to submit, please get in contact here.
Related media articles
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Media article: Preparing For The Biosimilar Era Of ADCs And BsAbs In Oncology
As patent expirations in oncology biologics increase, what are the opportunities, regulatory pathways and challenges this presents for developers? Publication: Citeline Generics Bulletin
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Media article: What sets oncology biosimilars apart: Anticipating key challenges in the development landscape
With patent expirations encompassing numerous notable oncology biologics, opportunities for oncology biosimilar development are abundant. Publication: Drug Discovery & Development Magazine
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Media article: The Evolving Cost-Benefit Landscape of Biosimilar Drug Development
The patent cliff for biologic medicines presents an opportunity for developers of biosimilars, but historically there are challenges too. But the landscape is changing.
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Media article: The U.S. biosimilars market: Shaking the “laggard” label
An article by Katya Svoboda and Bob Swann which explores the fundamental differences in the regulatory processes and the market dynamics of the US and the EU which account for much of the discrepancy in the uptake of biosimilars.
