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.