Shots:
The EMA has accepted the MAA for biosimilar natalizumab, a proposed biosimilar to Tysabr for highly active RRMS. Biosimilar natalizumab was developed by scientists at Polpharma Biologics
The MAA submission was based on analytical, preclinical & clinical data incl. P-III (Antelope) study to evaluate biosimilar natalizumab in patients with RRMS. The P-III (Antelope) & P- I trial met their 1EPs & shown that the effectiveness and safety of the biosimilar matched those of the reference drug
Under the 2019 agreement with Sandoz, Polpharma will be responsible for the manufacturing & supply of the product while Sandoz gets the rights to commercialize & distribute the proposed biosimilar
Ref: Polpharma Biologics | Image: Polpharma Biologics
