Case Study – Delivering Comparators for an Allergy Study
CSI was asked to support a client trial for sourcing of grass pollen allergen tests. There were 2 main concerns:
1. No product was licensed in all countries where the trial was running
2. Quantities required were considerable and the Sponsor was worried about the availability of the required quantity in the timelines to support the trial The client wished to utilise the same product for all patients enrolled to ensure consistency in trial results.
The client wished to utilise the same product for all patients enrolled to ensure consistency in trial results.
The Licensing aspect was clarified as the products are considered equivalent in literature, the composition was largely the same across products and the use of unlicensed products was common in many markets.
Due to the request for a large quantity of the same product the optimal sourcing strategy was a central model direct from a manufacturer. CSI decided the most pertinent option was to approach two independent manufacturers to protect the supply.
Challenges and Results
Using the evidence gathered by CSI on equivalency across products and the use of unlicensed medication the sponsor submitted with the two products to country regulators successfully.
Approaching two manufacturers was a prudent choice as when it came time to order the first choice could no longer support the quantity due to changes in production. The second-choice manufacturer was able to support the requested volume and the study ran to schedule.
Engaging CSI at the protocol design stage allowed the sponsor flexibility in sourcing strategy and provided a safety net with a backup option. The scientific expertise that CSI has was crucial in allowing the trial to follow a central sourcing model – minimizing risk of shortages in supply by only sourcing in one market.
The advantages of biosimilars vs branded products in clinical trials
The growth in the biosimilar market since 2006 has been significant.