Biosimilars: Development & Testing

Realize the market potential of biosimilars

With over 40% of today’s molecules developed as biologics, biosimilars represent a growing opportunity with significant market potential. However, developing a biosimilar and achieving market success is not a straightforward, one-size-fits-all process.

As the only CRO that can provide an integrated biosimilar development solution starting with CMC analytical characterization through nonclinical, clinical and market access activities, we can offer a holistic strategy and cross-functional expertise to optimize your biosimilar’s development. 

Navigate the regulatory landscape

During biosimilar development, many key issues need to be considered based on current regulatory guidance. You need a partner that can help you understand the requirements of different regulatory authorities, the important differences between EMA and FDA guidelines and to keep up with evolving recommendations. Working together, we can help prepare you for agency meetings and enable early engagement to help reduce your time and cost of navigating the global regulatory landscape.  

Get support from early phases through commercialization

Getting market access support – early in development – is another crucial area to achieving success in biosimilars. Rely on our experts to help you create a strong, analysis-based similarity package that considers the needs of payers, providers and patients so you can fully realize the value of your product.

Together, we can assess the competitive landscape and design a strategy for reimbursement that maximizes your market potential.  

Tap into extensive CMC

Controlling variability and assessing biosimilarity is the first step in a biosimilar’s successful development. Trust in our robust analytical approaches to enable physicochemical characterization, assess biosimilarity and identify risks by using the most optimal, fit-for-purpose testing methods.

Take advantage of our Biosimilar CMC Analytical Master Files – unique guides that serve as the foundation for risk-mitigated biosimilarity assessment, client data evaluation and consultation to support your biosimilar program throughout its development and product lifecycle. When your product reaches the market, we’ll help you maintain its availability through our GMP global batch release and stability testing. 

Get expert support for your nonclinical and bioanalytical needs

As the only CRO that can provide an integrated biosimilar development solution, your program is covered – from the very start. Let us support your nonclinical needs with in-vivo studies (efficacy/pharmacology, pharmacokinetic (PK) and toxicity), bioanalytical method validation and sample analysis, and immunochemistry including anti-drug antibody (ADA) and neutralizing antibody (NAb) assessment in animal and human matrices

Shorten timelines by streamlining Phase I and III studies

When you partner with a proven CRO, expect more than biosimilars expertise. With Labcorp, you’ll benefit from our global strategic partnership that includes the largest healthcare and research networks, with investigators experienced in biosimilars.

Our four global clinical research units and three hospital alliances have a combined 400-bed capacity to handle the needs of your phase I trials.

We’ll also help you work with the right clinical sites to deliver your patient studies by using real-world data from our Xcellerate^® Informatics Suite that identifies investigators with deep experience testing biosimilars and compounds in your therapeutic areas. As a result, you’ll make smarter site selection decisions, boost your recruitment rates and optimize your clinical trial.  

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