Profile
Client: Top 10 Global Pharma
Indication: Neurology
Process: Biotech
Market: Americas
IDrug
assignment
» In the markets within project scope, Biosimilars can gain regulatory approval without conducting non-inferiority studies vs. originator.
» Without the need to conduct such studies, biosimilars of our client's product had been launched in several key markets.
» As a large part of high cost treatments in the region are sold via government tenders based on lowest price, the potential impact on sales was substantial.
» Based on previously conducted internal analysis, the client suspected that some biosimilars formulations contained higher levels of impurities than the originator product.
» IDrug assignment was to benchmark the quality of biosimilar vs. originator formulations.

Client Objective

» Identify possible differences of biosimilars vs. originator formulations.
» Provide scientific input for the discussion of such differences with key opinion leaders, health authorities and patient associations.