Logo

Sandoz Reports the US FDA and EMA's Acceptance of BLA & MAA for Natalizumab, a Proposed Biosimilar to Tysabri to Treat Multiple Sclerosis

Share this
Sandoz Reports the US FDA and EMA's Acceptance of BLA & MAA for Natalizumab, a Proposed Biosimilar to Tysabri to Treat Multiple Sclerosis

Sandoz Reports the US FDA and EMA's Acceptance of BLA & MAA for Natalizumab, a Proposed Biosimilar to Tysabri to Treat Multiple Sclerosis

Shots:

  • The US FDA has accepted the BLA for proposed biosimilar natalizumab that comprises all indications covered by reference natalizumab for MS incl. CIS, RRMS, active secondary progressive disease & CD. The therapy was being developed by Polpharma Biologics
  • The EMA also accepted the MAA for the proposed biosimilar natalizumab in RRMS.  The submission was based on the comprehensive data package incl. P-I & III (Antelope) study which met their 1EPs & showed that the biosimilar was equivalent to the reference natalizumab in terms of efficacy, safety & immunogenicity
  • If approved, the biosimilar can increase access & deliver savings for healthcare systems. Under the 2019 agreement with Polpharma, Sandoz has the rights to commercialize the biosimilar in all markets

Ref: Globe Newswire | Image: Sandoz

Click here to­ read the full press release 

Neha

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.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions