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FDA Approves First Biosimilar Treatment for Multiple Sclerosis

James L. Flint

• August 25, 2023

Biogen Inc. shares slipped in the extended session Thursday after the Food and Drug Administration (FDA) granted approval for the first biosimilar treatment of multiple sclerosis. Sandoz Inc., a soon-to-be spinoff of Novartis AG, received the FDA's approval for Tyruko, the first biosimilar to Biogen's Tysabri. Tyruko is indicated for the treatment of adults with relapsing forms of multiple sclerosis, as well as adult patients with moderately to severely active Crohn's Disease.

The Rise of Biosimilars

Biosimilars are similar to generic drugs in relation to branded biologics, but they are regulated differently by the FDA. While generics provide more affordable alternatives to branded pharmaceuticals, biosimilars aim to offer similar efficacy and safety profiles at potentially lower costs.

Novartis' Focus on Generics and Biosimilars

Novartis recently announced plans to spin off its generics and biosimilars business, Sandoz, in October. As part of this strategy, CVS Health Corp. revealed its intention to collaborate with Sandoz on producing a biosimilar to AbbVie Inc.'s Humira, a popular treatment for various autoimmune conditions.

Biogen's Journey with Tysabri

Biogen first received FDA approval in 2004, in partnership with Elan Corp., to market Tysabri as a treatment for multiple sclerosis. In its recent July earnings report, 32.4% of Biogen's U.S. product revenue was attributed to Tysabri, with U.S. sales reaching $259.9 million in the June-ending quarter.

Despite the FDA approval of Tyruko and its potential impact on competition, Biogen managed to maintain its position in the market. Although its shares dipped 0.5% after hours, this follows a minor decline of 0.9% during the regular trading session, closing at $262.43.

With the approval of Tyruko and the continuous development of biosimilars, the medical industry is witnessing significant advancements in providing alternative treatment options for patients with multiple sclerosis and other related conditions.