US FDA gives approval to Samsung Bioepis’ Humira biosimilar and Pfizer’s Rituxan biosimilar, as the number of such medicines gaining entry onto the US market steadily increases.
Celltrion and Teva have overcome regulatory hurdles to secure approval for Truxima in the US, a biosimilar to non-Hodgkin’s lymphoma treatment, Rituxan.
After the business was asked by the US FDA to provide more data to secure an approval for its biosimilar, Sandoz decided not to pursue its regulatory filing any further.
