Analytical evidence is becoming the cornerstone of biosimilar development. With regulators increasingly open to reducing certain comparative clinical efficacy studies, the quality of bioanalytical data has never been mo...
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 including Pharmacokinetic Similarity Studies (PKSS) and Comparative Clinical Efficacy Studies (CES), therapeutic expertise, clinical pharmacology, pharmacokinetics, regulatory strategy, bioanalytical labs, CMC and biostatistics.
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41
Biosimilar trials -
2,400+
Research sites -
11,000+
Patients and healthy volunteers
Over the past five years, ICON has participated in 41 biosimilar trials across key therapeutic areas including immunology, oncology, endocrinology and gastroenterology, in dozens of countries, engaging 11,000+ patients and healthy volunteers at 2,400+ research sites.
Our experience spans early-stage consulting through to regulatory approvals and commercialisation, ensuring that our clients are supported at every stage of development.
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 Engage AI (actionable customer feedback), 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.
Making sense of the rapidly changing biosimilars landscape
Strategies for adapting and achieving optimal market access
This whitepaper explores market trends in biologics, development impacts of new EMA and FDA regulatory shifts and how originator companies may respond to biosimilar competition.
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)
Our services include:
Bioanalytical laboratory services
Dedicated to clinical development, our bioanalytical labs support testing methodology, ensuring high-quality comparability data
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
Design and execution of global clinical plans
We develop detailed clinical strategies and optimised protocols that meet regulatory requirements
Market access and commercialisation
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: The Next Wave of Biosimilars: Why Hematology Is a High-Stakes Opportunity
A confluence of patent expiries and rising healthcare costs are accelerating both interest and investment in biosimilars across the world. Nowhere is this more apparent than in hematology.
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Media article: Biosimilar Success in an Evolving Landscape: Development Considerations for Staying Competitive
Discover how developers can stay ahead and position their programs for more efficient market entry, read the article by ICON’s Head of the Centre for Biosimilar Drug Development
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Media article: Faster Doesn’t Mean Easier: Development Impacts of a New Biosimilar Regulatory Landscape
Regulatory authorities have made it clear that streamlining biosimilar development is a priority, following the example of the EMA and FDA in reducing the requirements for comparative efficacy studies. Read this article to understand the recent changes and their impact.
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Media article: Overcoming Formulation Challenges for Biosimilars
Media article discussing how high-concentration formulations and patient centricity are challenges to the formulation of biosimilars, which already face patent protection barriers.
