Sandoz: Biosimilar Tyruko Gets Approval In Europe To Treat Multiple Sclerosis

(RTTNews) - Sandoz, a unit of Swiss drug major Novartis AG (NVS), announced Tuesday that the European Commission granted marketing authorization for Tyruko (natalizumab) for multiple sclerosis in Europe.

The company noted that biosimilar Tyruko, developed by Polpharma Biologics, has been approved for all indications of reference medicine, as first and only biosimilar to treat relapsing forms of multiple sclerosis or MS in Europe.

The authorization covers treatment as a single disease-modifying therapy or DMT in adults with highly active RRMS, the same indication as approved by the EC for the reference medicine Tysabri (natalizumab).

The EC decision was based on evidence from extensive analytical characterization demonstrating similarity of biosimilar with reference biologic, in addition to Phase I and confirmatory Phase III studies.

MS is a chronic inflammatory and neurodegenerative disease of the central nervous system. Early treatment with DMTs can change the course of a person's MS and reduce future disability.

It was in 2019 that Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics. Under the deal, 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.

Rebecca Guntern, President Europe, Sandoz, said: "Multiple sclerosis is a chronic condition with no cure at present and timely access to affordable, high-quality healthcare is therefore even more essential. Today's approval brings us one step closer to reducing the burden of this disease for those living with multiple sclerosis in Europe by making the life-enhancing treatments they need more accessible."

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