Biosimilars can be used in place of a branded drug (if one exists), offering the sponsor a variety of benefits. But what is a biosimilar, exactly? Can a sponsor just replace the branded drug with the biosimilar, or are there certain requirements that need to be met in order to use it in a clinical trial?

Summary: The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Selecting the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors successfully navigate these challenges.

The role that comparator sourcing specialists play throughout the end-to-end clinical supply process

Ensuring an adequate, timely, and quality supply of comparator product for clinical trials is critical, but clinical trial sponsors face several challenges in this endeavor.

Ensuring an adequate, timely, and quality supply of comparator product for clinical trials is critical, but clinical trial sponsors face several challenges in this endeavor.

Summary: A short video on Catalent's flexible and innovative clinical supply services for phase 1-4 clinical trial sponsors. We have the deep expertise, global capabilities and...

Summary: Clinical trials are conducted according to a protocol, which is the master action plan for how the study will be conducted. Clinical trial protocol design can have a significant impact on the sourcing...

Summary: Clinical trial protocol design can have a significant impact on the commercial drug sourcing strategy for a study requiring comparators. Learn the appropriate level of detail to include in the study protocol...

When you use Catalent for pharmaceutical sourcing, you get a global distribution network that can deliver what you need, where you need it and when you need it. Always in the right condition...

Summary: A well-known, mid-size, multi-national pharmaceutical company needed a large supply of comparator drug, in order to begin comparative clinical trials for a rare disease. In addition to quantity, the comparator drug must have an expiry-term long enough for the client to complete the multi-year clinical trials...