CHMP recommends approval for Tyruko a multiple sclerosis biosimilar natalizumab
Sandoz, a global leader in off-patent (generic and biosimilar) medicines, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorization for first-of-a-kind biosimilar natalizumab (Tyruko) developed by Polpharma Biologics
The authorization covers treatment as a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS), the same indication as approved by the EMA for the reference biologic.
Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibilities for development of medicine, manufacturing, and supply of drug substance. Through an exclusive global license, Sandoz has the rights to commercialize and distribute it in all markets.
The comprehensive analytical, preclinical, and clinical data regulatory submission package included evidence derived from an extensive analytical characterization, in addition to results from a Phase I PK/PD study and a confirmatory Phase III Antelope study in RRMS patients. Both studies met their primary endpoints, showing that the biosimilar matches the reference biologic in terms of pharmacokinetics as well as efficacy, safety and immunogenicity..
Tysabri (natalizumab) patents expired in the EU in 2015 and in the US in March 2023.
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