Case Study – Overcome Shortages by leveraging Relationship with Manufacturer
CSI had an urgent request to supply a large quantity of a generic drug for an ongoing Phase 3 trial. These products were initially overlooked as it was assumed the sites would supply. When this turned out to not be feasible it was close to trial initiation date, so timelines were extremely tight to deliver and keep the trial on track.
CSI carried out extensive research to determine what drugs were licensed in the participating countries that spanned three continents. All major generic manufacturers where approached to ensure coverage over all regions, working closely with these manufacturers CSI executed a literature review and procured equivalency statements for the products required.
Approaching a range of manufacturers allowed CSI to present an option that could cover all countries in the trial, the equivalency statements provided the appropriate justification to prove clinical equivalency across products that allowed the trial to go ahead.
Challenges and Results
Liaising with multiple manufacturers and the client to ensure not only the supply of medication but also to prove equivalency between products was a very challenging task. It required a high level of scientific expertise and knowledge of clinical trial regulatory requirements.
Ultimately the strategy was a success and allowed the trial to begin without delay. This experience highlights the importance of appropriately planning the sourcing of comparator and co-medication at an early stage in the clinical trial process. Leaving it to the last minute, as was done here, not only increases the risk of delaying trial initiation but can massively increase the costs associated with sourcing these materials.
The advantages of biosimilars vs branded products in clinical trials
The growth in the biosimilar market since 2006 has been significant.