To market a biosimilar product, manufacturers need to perform a head-to-head comparison with its original counterpart, the reference medicinal product (RMP). This process, called biosimilar exercise, aims to highlight the variation in the original manufacturing process and the similarity between biosimilars and the reference products.
This is a necessary procedure obtain authorization from regulatory bodies such as EMA (European Medicines Agency) and FDA (Food and Drug Administration) to produce a biosimilar within a given range of variation.However, this requires highly specialized sourcing capabilities to provide enough batches of the reference molecule to fully appreciate these differences.
We source and prepare, you choose what you need
While general pharmaceutical sourcing specialists may provide RMPs for biosimilar exercises, these usually do not take into consideration manufacturing variations between individual batch productions. Biosimilar developers have then difficulties to obtain multiple RMP batches at the same time, and this of course slows their work and, by extension, the development of new biosimilar products.
Evidentic manages all the sourcing of RMPs at both early and late stages of your biosimilar exercises. We source multiple RMP batches, to prepare, stock, and keep them available for you at all times. This assures that different batches of the reference molecule are available for your research, and delivered in a single shipment, reducing artifacts in your results. We provide all the information required not only for an informative analysis, but also comply with EMA and FDA requirements for biosimilar development.
Our services make your analytical work simpler, more accurate, and cost-effective, allowing you to bring your biosimilars to the market sooner.
Biological medicinal products available for order now
Our reference product library stocks multiple batches of different reference medicinal products (RMPs) at all time. We provide different production batches of RMPs from the European Union, offering you the right analytical tools to develop your biosimilar products for this market.
We offer you highly transparent sourcing, stocking and handling. On our product page you will find batch-specific information for all our products. We make sure that the stocking and handling procedures comply with European guidelines for good manufacturing practices, making sure that our products maintain their characteristics. We also provide comprehensive information on origin and handling of each sample, to make your analysis as simple as possible.