Reference Drug Supply –
Accelerating access to reference drugs needed for generic and biosimilar development
Novus Clinical provides global access to Reference / Originator Drugs to enable sponsors to run their Generic and Biosimilar drug development programs.
Our team of experienced specialists collaborate with you to understand the specific requirements of the project, then work proactively to identify the optimal supply solution.
Ready to work with us?
Let us guide you through the complexities of the clinical supply process. Speak with our team of experts today.
Let's talkBiosimilars
Pre-Clinical (Reference Library)
We supply small volumes of the Originator / Reference product from various batches, expiries and countries in order for the Biosimilar developer to create a “reference product library”.
Phase 1 (PK & PD Study)
We supply hundreds of packs of the commercial marketed Originator / Reference Product in order for the Biosimilar developer to run their PK and PD of their investigational product against the Originator / Reference product.
Phase 3 (Efficacy & Safety Study)
We supply thousands of packs of the commercial marketed Originator / Reference drug, along with associated documentation (CoA, CoC, Equivalency Statement) to support the Ph3 confirmatory efficacy and safety study .
Generics
Pre-Clinical (Reference Library)
We supply small volumes of the marketed Reference Listed Drug (RLD) from various batches, expiries and countries in order for the Generic developer to create a “reference product library”.
Bioequivalence Study
We supply tens to hundreds of packs of the Reference Listed Drug (RLD) in order for the Generic developer to run their Bioequivalence study.
