Biosimilars Clinical Trials Design and Execution: Challenges from Sponsor Perspective

Laura Ullate, Marta Gomez-Serranillos, Fernando Maellas, Luis Perez, Susana Millan
Clinical Operations, Mabxience, Spain

Biological products represent 20% of the global pharmaceutical market with a $200.000 mill value, expecting to grow up to 70% in the upcoming 2 decades. It implies an enormous spending for the patients and health systems. Currently 146 biosimilar molecules are in research under 642 clinical studies that will help the accessibility and sustainability of the health system. The main area of application will be Oncology (36%).

Biosimilar drugs have become an effective and economical option to approach oncology treatments. Regulatory Agencies, sponsors and investigators should make an effort to adapt their working methods to the development of alternative drugs that will change the oncology panorama treatment within the next years.

Biosimilar clinical development projects face a number of unique operational challenges related to executing clinical trials. Key Performance Indicators and data collected in two biosimilar Oncology studies were studied: Rituximab biosimilar (RTXM83 - 256 Non-Hodking Lymphoma patients, 88 sites, 13 countries) and Bevacizumab biosimilar (BEVZ92 - 140 colon cancer patients, 15 sites, 5 countries).

Designing global clinical studies, selecting the population needed according to the different regulatory requirements due to lack of harmonized biosimilar guidelines, reference medicinal product suppliers selection, difficulties in purchasing and obtaining support documents, poor scientific motivation and sometimes insufficient investigators’ biosimilar knowledge, patients´ low interest to participate depending on reference medicinal product accessibility and complete treatment price are some of the main challenges that a sponsor needs to face when it comes to developing a biosimilar clinical trial.

Consequently, sponsors have to reinvent the clinical trial approach and strategy turning upside down former tactics. Design, study set-up, country and site selection, executing and monitoring and controlling processes have been completely shifted to respond to major changes in needs or context.