Sourcing innovator products for biosimilar development
The basic principle underlying the development of a biosimilar product is the comparability with the innovator product. For this critical concept that has been evolved in order to perform comparisons between different versions of any biological products in development it is nessesary to source enough material of the innovator product in the right specification (batch, origin etc.).
Due to our long experience in protein analysis and characterization for biosimilars, we understand that sourcing innovator products for biosimilar development can represent many challenges. Shortages, manufacturers restrictions, documentary difficulties and government regulations can make sourcing difficult.
We have extensive experience in sourcing products for biosimilar studies. We incorporated innovative solutions by purchasing directly from innovator companies, ensuring pedigree of products and continuity of supply, with different batches and expiry dates. In addition, we have sourced specifically for analytical purposes, before and after the launch of an innovator product.
We have established an excellent track record in the development of biosimilars, delivering even the most difficult to source products.
Appropriate sourcing service
While at initial stages of biosimilar development clients require a range of different reference products, their request may change at a later stage of their research and development program.
For the intitial analytical work packages we can source and deliver off-the-shelf medicinal products. At this stage, Evidentic will function as a pharmaceutical sourcing specialist for its clients.
Tailored analytical solutions for your late-stage biosimilar exercise
We can offer custom sourcing requests at all stages of the product developmental cycle, particularly during the authorization phase of biosimilar development projects.
These may include supplying samples from specific batches or larger amounts of reference medicinal products, for example. With years of experience as sourcing specialist for the pharmaceutical industry, we know the market and how to satisfy the requests of our customers.
Our customers come from various sectors such as the pharmaceutical industry, to biosimilar developers and to analytical laboratories at commercial and non-commercial institutions.