On 4 April 2025, Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), was approved by Australia’s Therapeutic Goods Administration (TGA). This is the first biosimilar natalizumab approved in Australia.
Tyruko®’s Australian approval is for a 300mg/15mL concentrate for infusion vial. It is indicated as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (MS) to delay the progression of physical disability and to reduce the frequency of relapse.
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) considered Tyruko® for reimbursement at its March 2025 meeting. The outcomes of that meeting have not yet been published.
Tyruko® was developed by Polpharma Biologics and, under a global commercialisation agreement with Sandoz reached in 2019, Sandoz has exclusive rights to commercialise and distribute the product in all markets.
Tyruko® is approved in Europe (September 2023) and the US (August 2023).