Comparator Drug Sourcing

Fisher Clinical Services surveyed the Clinical Trial Community to better understand your comparator sourcing needs — and the results revealed some

compelling insights. Below you will find some of the survey findings along with a few tips from Fisher Clinical Services.

How strategic is your comparator sourcing approach? Finding: Almost half of respondents indicated that they are utilizing preferred providers or a single source approach to comparator sourcing.

Tip: Reducing waste and overage by leveraging initial and ongoing forecasting and simulation is the key to reducing clinical trial costs.

Insight: Half of the respondent reported that product availability and timelines as their top challenge. For open market sourcing the timeline is short but product availability can be a hurdle. The larger the quantities of comparator the clinical trial manager has to procure, the more dependent they become on sourcing through the originator. This can add 3-5 months to the sourcing timeline. Tip: Reach out to your provider of comparator drugs early in the development process and before key clinical trial protocol details have been finalized. At that point, there is big opportunity for the supply chain manager to offer recommendations that could increase the efficiency and cost-effectiveness of the trial.

Top challenges when sourcing comparator

Finding: Up to 50% of total clinical supply cost can be spent on comparator drugs*. This is why 15% named financial aspects as their second biggest risk. Forecasting, simulation and waste management for biologic drugs are becoming increasingly critical activities within the supply chain. Taking the precautions necessary to mitigate the risk of counterfeit products entering the supply chain remains on top of the list. Tip: Some countries are “safer” than others, depending on the level of regulatory requirement of Medicines Regulatory Authority/Drugs Regulatory Agency for each country and the frequency of occurrence of counterfeit drugs in these countries according to WHO and International Medical Products Anti-Counterfeiting Taskforce.

Biggest risk when sourcing comparator drugs

Finding: Not being able to supply to a certain country with central sourcing is the main reason for local sourcing. Followed by the advantage of cutting lead-times. Tip: Download our White Paper to learn more about Comparator Local Sourcing and the best practices to follow.

The most challenging countries/regions to source Finding: Almost 40% named China as the most challenging country to source comparator from due to local laws and regulations. Tip: In China, local sourcing is permitted only from Chinese legal entities and payment must be made in the local currency, the renminbi/Yuan. In case you do not have a Chinese legal entity you could leverage the Fisher Clinical Services site in Beijing or our Suzhou site in the Free Trade Zone.

Main reason for using local sourcing instead of central sourcing

Biggest concern for biosimilar phase III trials related to comparator sourcing Finding: A third of the biosimilar companies reported that access to documentation is their biggest concern. This was followed by comparator overage or waste as the second largest concern. Waste and overage drives up biosimilar development cost and could negatively impact market price at time of product launch. Tip: Rely on a partner who negotiates with commercial supply chain managers to get access to documentation for clinical trials. Reach out as early as possible to a supplier with a large sourcing network.