Polpharma Biologics Report EMA's Acceptance of MAA for Biosimilar Natalizumab, a Proposed Biosimilar to Tysabr for Relapsing-Remitting Multiple Sclerosis
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
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
