The Sandoz unit of Switzerland-based Novartis (NYSE: NVS) has received regulatory clearance from the US Food and Drug Administration (FDA) for Tyruko (natalizumab), marking it as the first biosimilar version referencing Biogen’s (NASDAQ: BIIB) blockbuster biologic Tysabri. Both monoclonal antibodies (mAbs) are indicated for treating Crohn’s disease and relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease.
Equivalence in Efficacy, Safety, and Immunogenicity
The approval was supported by results from Phase I and Phase III studies, which demonstrated that Sandoz’s biosimilar is equivalent to Biogen’s originator in terms of efficacy, safety, and immunogenicity. This equivalence is crucial for patients and healthcare providers, ensuring that they have access to a cost-effective alternative without compromising on the quality and effectiveness of treatment.
Sandoz’s Global Commercialization Rights and Impact on Tysabri Sales
Sandoz in-licensed Tyruko from Polpharma Biologics in 2019 and currently holds global commercialization and distribution rights for the biosimilar. The introduction of Tyruko is expected to erode Tysabri’s sales, which reached USD 2.0 billion in 2022, making it Biogen’s top-selling drug. The entry of a biosimilar provides a significant opportunity to increase patient access to this critical therapy while potentially reducing healthcare costs.-Fineline Info & Tech
