“Clinical trial success is the key to confirming biosimilarity for biosimilars and making them available for a large patient population”
Karsten Roth, Director Clinical Research and Development
Our clinical development and operations group plan and manages pre-clinical and clinical trials from phase 1 to phase 3. These include first -in-man, PK/PD trials and international multicentre phase 3 trials in various indications.
Designing clinical trials for biosimilar in close alignment with regulatory agencies is critical and sensitive tool to confirm the biosimilarity of our products to the originator and to ensure that the products are safe for the patients that need them most.