Some of the problems associated with sourcing reference drugs are:
- Finding reference drugs is time-consuming and stressful: Factors such as availability, batch size (single- vs. multi-batch), different dosage forms and price can vary strongly in different regions of the world adding further complexity.
- One batch is not enough: Biosimilars development requires many different RLD batches that can stretch the development process to a couple of years.
- Inconvenient, large sample sizes: drug developers must buy reference drugs in regular-sized quantities and presentations as licensed by the authorities, whereas for several analytical studies and assays only a small amount of the reference drug is needed.
- License: both buyer and seller organizations must hold a wholesale dealer license (WDL) to trade pharmaceutical drugs.
Evidentic’s CEO Dr. Christian Schmitz has found a unique and easy solution to these problems. Evidentic divides and repackages the original finished pharmaceutical products into analytical quantities. The repackaged pharmaceuticals are referred to as ‘drug aliquots’ and are prepared in a laboratory process called aliquotation. Thus, converting difficult to procure reference drugs into a research consumable. These drug aliquots can be ordered online and delivered within a week.
“Evidentic is really the only company in the world that can provide any reference drug in aliquot format at a reasonable price. Our customers are very happy with the quality of product,” says Dr Christian Schmitz, CEO at Evidentic GmbH.
Dr Neha Dhimole, Business Development Manager, “Biosimilar companies who have used our drug aliquots are impressed with the quality and have seen their development time shortened.”
Evidentic offers their service to companies located in the EU, Asia Pacific and the USA.
- Easy access to analytical quantities of reference drugs as ’drug aliquots’.
- A convenient, reliable source: all the drug aliquots are derived from EU-licensed commercial reference drugs and aliquoted in a certified GMP lab.
- Fast access to reference drugs made possible through a digital ordering process.
- A Batch library of reference drugs for biosimilar development: Different lots of reference drugs with a range of batch numbers and expiry dates are available. The desired batches can be ordered from our website.
- Quick and specialized delivery that ensures careful handling of temperature-sensitive biologic material.
- Special price advantage is made possible by providing reference drugs in aliquots. The drug aliquots are considerably cheaper than purchasing the full vial which saves time, resources and reduces waste of precious drug products.
Headquartered in Berlin, Germany, Evidentic provides biosimilar and biopharma developers, research organizations, and contract research and manufacturing companies with analytical quantities of reference drugs. The company currently sources reference drugs from EU member states and ships to customers worldwide. For more information please visit our website.