Sandoz secures landmark FDA approval for biosimilar of Biogen’s Tysabri

USA — In a groundbreaking move, the U.S. Food and Drug Administration (FDA) has given its nod to Tyruko (natalizumab-sztn), a biosimilar designed as a counterpart to Biogen’s Tysabri (natalizumab) injectable treatment for multiple sclerosis (MS).

Developed by Polpharma Biologics and marketed by Novartis’ Sandoz unit, Tyruko marks a historic achievement as the first biosimilar product to gain approval in the U.S. for patients grappling with MS.

Tyruko’s scope encompasses the treatment of relapsing forms of MS, encompassing clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Parallel to Biogen’s innovation, Tyruko is also indicated for inciting and sustaining clinical response and remission among adults contending with moderate-to-severe active Crohn’s disease, for whom conventional therapies and TNF-α inhibitors are unsuitable.

The FDA’s stamp of approval arises from a compelling body of evidence showcasing the absence of “clinically meaningful differences” in terms of safety, purity, and potency between Tysabri and Sandoz’s Tyruko.

Paul Lee, Director of the Division of Neurology II within the FDA’s Center for Drug Evaluation and Research, underscores the potential impact of this milestone, emphasizing that “biosimilar medications offer additional effective treatment options.”

Natalizumab products, including Tyruko and Tysabri, come with a boxed warning concerning progressive multifocal leukoencephalopathy.

In response, the FDA has mandated a risk evaluation and mitigation strategy (REMS) for natalizumab products, underscoring the agency’s commitment to safety.

Biogen’s shifting landscape and Sandoz’s bio-journey

In the backdrop of evolving market dynamics, Biogen’s Tysabri reported sales of US$483.1 million in Q2, signaling a dip from the previous year.

On the other hand, Sandoz’s Tysabri biosimilar journey is on the upswing, bolstered by a positive opinion from the EU’s drug advisory body.

The collaborative strength of Sandoz and Polpharma, established in a 2019 partnership, resonates through Tyruko’s development, manufacturing, and commercialization.

As Sandoz gears up for its anticipated spin-off from Novartis, its biosimilar aspirations are gaining momentum.

The unveiling of biosimilars for AbbVie’s Humira, Eylea from Bayer and Regeneron Pharmaceuticals, and Amgen’s Prolia/Xgeva in 2024 mirrors Sandoz’s commitment to broadening affordable treatment access.

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