Regulatory & Clinical Development

Successful biologics development requires a deep understanding of the complex structure of the molecule including all potential functional activity pathways.  In addition, the capability to consistently and robustly manufacture high quality product is also essential.  A seamless integration of regulatory requirements with this in-depth technical knowledge of each molecule is a critical cornerstone for building cohesive non-clinical and clinical development programs.

At Oncobiologics, regulatory and clinical functions are fully integrated in the technical development of every molecule.    Building off of the quality data generated by experienced Oncobiologics technical teams, the regulatory and clinical functions work with expert contract organizations to develop innovative clinical development and regulatory plans to speed time to Clinical Trial Application and through filing of the marketing applications.

Oncobiologics has pursued a proactive partnering strategy with key Health Authorities, seeking early and ongoing input to optimize our development plans.  Oncobiologics incorporates feedback from these regulatory interactions to understand the evolving regulatory landscape to better assure acceptance of our registrationalplans.  To date, Oncobiologics has interacted with EMA and FDA on multiple occasions and through these strategic discussions, we are developing streamlined approaches in our biosimilar development.