Sandoz’ Tyruko (biosimilar, natalizumab) Receives the US FDA’s Approval as First Biosimilar for Relapsing Forms of Multiple Sclerosis
Shots:
- The US FDA has approved Tyruko, the first biosimilar to Tysabri (natalizumab) for all indications covered by reference medicine with the same dosing and administration schedule for relapsing forms of MS incl. CIS, RRMS, and active secondary progressive disease, as well as Crohn’s disease in adults
- The approval was based on robust P-I & III clinical studies which met their 1EPs and showed Tyruko provides the same risks and benefits in terms of efficacy, safety, and immunogenicity as reference Tysabri
- The biosimilar treatment is available via a Risk Evaluation and Mitigation Strategy (REMS) program due to the identified risk of the viral infection progressive multifocal leukoencephalopathy (PML)
Ref: Novartis | Image: Sandoz
Related News:- Sandoz Receives EMA’s CHMP Positive Opinion of Biosimilar Natalizumab for Multiple Sclerosis
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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.
