As mentioned on the Fisher Clinical Services blog post, biosimilar clinical trials require complex sourcing strategies, as well as large quantities of biological comparator drug. Developing the sourcing strategy is an important task that falls on the Supply Chain Manager’s shoulders. However, the task is not as easy one due to many factors (time pressure to start the clinical trial, high drug costs, investigator site locations… just to name a few, and more!), and various sourcing strategies for the biosimilar trial must be considered.
The first option to consider is direct sourcing. Direct sourcing for biosimilar trials has a couple of advantages: a robust clinical supply chain, access to documentation required for logistics and access to products with the longest possible remaining shelf life. However, it may not be ideal for fast pace phases such as first supply campaign or emergency resupply due to lead times that can range anywhere from 3 to 6 months following order placement.
The second option to consider is open marketing sourcing. Open market sourcing offers the following advantages to biosimilar trials: speed, flexibility and price. When sourcing through the open market you are provided the quickest possible access and can therefore accelerate your study start-up. Its flexibility supports early urgent supply and provides rapid responses to changes in patient recruitment levels without setting the clinical trial timelines at risk. Also, when it comes to pricing, you’re likely to find this a viable option in order to cut clinical trial costs due to lower market prices. However, open market sourcing does not provide any guarantee to secure your supply chain and rarely comes with full documentation.
Which option is a savvy supply chain manager to choose? Supply chain managers may find it beneficial to consider a hybrid sourcing strategy for biosimilar trials. In other words, leveraging the positives from both direct and open market sourcing.
The following 3-step approach can be useful in these circumstances:
- Sourcing the initial amount of comparator drugs through the open market, which supports a fast study start-up, keeping in mind country starting dates for importation (supply without documentation may not be suitable for importation into certain countries).
- As you anticipate your needs to grow above the open market availability in the next 3-6 months, plan ahead resupplies using direct sourcing in order to fulfill your trial need with a de-risked comparator supply using a strong and reliable source.
- In order to anticipate out-of-stock, in case of fluctuation in supply requirements, or in case of targeted last supply needed to control waste, sourcing through the open market comparator drugs should be your contingency plan for countries where you can import those drugs.
It’s important to note that while there is not a one size fits all sourcing strategy for every biosimilar trial, a hybrid solution provides a strong supply chain when it’s needed, the best lead times for study start and the flexibility to adapt to the reality of the trial, while offering comparator drugs at a lower unit price on average.