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Biogen nabs FDA nod for biosimilar version of Roche's blockbuster Actemra

2023-10-02

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Biogen and Bio-Thera Solutions' biosimilar to Actemra is the first in the industry to win an FDA approval.

Biogens BioBio-Thera Solutionsc options for its biosimilars unit, the group is celebrating an industry first.

Biogen’sBiogenon of Roche’s autoimmune drug Actemra has won FDA approval, the company said Friday. The drug becomes the first biosimilar alternative to Actemra to gain an agency nod.

Biogenbranded as TofRochee, the biosimilar, also known as toFDAizumab-bavi, has been approved to treat severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis, Biogen said in a release.

That trio of usesTofidenceort of Actemra’s full list of FDtocilizumab-baviations: The Roche drug also carries FDactive rheumatoid arthritisicpolyarticular juvenile idiopathic arthritisease,systemic juvenile idiopathic arthritis CBiogen9 patients.

Roche’s Actemra generated 2.7 billion Swiss francs last year, or nearly $3 billion, soRochedrug represents a major target for biosimisystemic sclerosis-associated interstitial lung diseaseedgiant cell arteritisears because of itCOVID-19ation in fighting the coronavirus.

Roche, as the pandemic eased in 2022, the drug’s sales fell by 22% compared with 2021.

The exact launch timing of Biogen’s biosimilar remains unclear. Biogen said it's "currently evaluating the potential launch timeline" for the drug.

In its annual finance reporBiogen) for 2022, Roche said its primBiogentents for the branded drug have expired in the U.S. and Europe. The first biosimilars to Actemra could launch in the second half of 2023, Roche said in the report.

Meanwhile, Tofidence’s FDA approval comes as Rochen weighs strategic options for its biosimilar group.Roche

Over the summer, rumorsFDArfaced that Biogen’Biogentime partner Samsung Bioepis was eyeing a potential purchase of the unit. But that deal has not come together.