Companies developing generic versions of marketed drugs utilize Celerion’s long-standing expertise and experience in the conduct of bioequivalence studies for market registration. Our scientists have successfully deployed adaptive and multiple treatment period designs to optimally manage bioequivalence studies of drugs with highly variable pharmacokinetic characteristics. Celerion is participating in the emerging area of biosimilar drug development by leveraging biologics regulatory expertise, proven large molecule and immunogenicity bioanalytical support, clinical study planning and execution and biopharmaceutics program development.
Having worked with a large network of clinical sites in Europe managing oncology and autoimmune drug studies, Celerion is well positioned to support the entire clinical development of biosimilar candidates. This includes not only managing clinical study conduct but supporting services such as immunogenicity assessment, bioanalysis, functional assays, data analysis and preparation of clinical study reports to regulatory standards.