A Partner for Global Biosimilar Development

PAREXEL’s unique blend of scientific, regulatory, clinical, technology, and business resources make us the ideal partner to help you meet the challenges of biosimilar development. With our unparalleled therapeutic expertise, comprehensive service offerings, and global access to diverse patient populations, PAREXEL can support every aspect of your biosimilar program – from Early Phase testing through regulatory submissions.

Equally important, PAREXEL is already a well-established, recognized leader in biosimilar product development. We have conducted more than 100 consulting and clinical projects for follow-on proteins, and supported two successful EMEA biosimilar submissions. Our experience includes numerous Phase I biosimilar studies and more than 30 Phase III biosimilar trials covering more than 3,500 patients. PAREXEL has also worked closely with the EU on the development of regulatory approaches for monoclonal antibody biosimilars in areas such as oncology and anti-inflammatory therapies. No other CRO offers this depth and breadth of experience in biosimilar products.

PAREXEL's extensive experience with biosimilar compounds make us one of the few companies that truly understands the regulations, the opportunities and the challenges of developing biosimilars. To speak to someone at PAREXEL regarding your plans, please email info@parexel.com.