A client approached us with a request for a large quantity of an expensive oncology product, documentation such as Certificate of Analysis (CoA) was required for import into several of the countries involved in the trial.
Due to the high value of the product and the importance of choosing a suitable strategy for the trial and sponsor CSI decided to investigate a range of options with different advantages and disadvantages so that the client could decide what best suited their trial. The solutions presented to the customer where;
1. Directly contact the marketing authorization holder (MAH) of the branded product.
Advantages: Guaranteed supply, single batch, full documentation, midlength lead time.
Disadvantages: Highest price of the options.
2. Source from authorized wholesalers in the open market.
Advantages: Cheaper than option 1.
Disadvantages: Susceptible to market changes – supply is less secure, longest lead time, CoA only available form some (small) markets – increases risk to supply chain.
3. Source a Biosimilar product registered in the USA and Europe directly from the biosimilar manufacturer.
Advantages: Cheapest price, guaranteed supply from manufacturer, quickest lead time
Disadvantages: Using a biosimilar in a trial can introduce pressure from regulators to prove equivalent clinical effect as the branded product.
CSI worked closely with the manufacturer of the biosimilar and was able to provide an extensive metaanalysis alongside equivalency statements to prove that the biosimilar was equivalent to its branded counterpart.
Challenges and Results
Using the meta-analysis and equivalency statements provided by CSI the sponsor was able to justify the use of the biosimilar option for the trial. This option allowed timely sourcing with full documentation at a massive cost saving, over the course of the study the sponsor saved in excess of €7 million compared to the branded option.
This was a remarkable achievement for CSI and our client. We demonstrated our scientific knowledge, expertise, and ability to deliver novel solutions.