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

Even as Biogen weighs strategic options for its biosimilars unit, the group is celebrating an industry first. 

Biogen’s version 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. 

To be branded as Tofidence, the biosimilar, also known as tocilizumab-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 uses falls short of Actemra’s full list of FDA-approved indications: The Roche drug also carries FDA approvals to treat systemic sclerosis-associated interstitial lung disease, giant cell arteritis and hospitalized COVID-19 patients. 

Roche’s Actemra generated 2.7 billion Swiss francs last year, or nearly $3 billion, so the drug represents a major target for biosimilar developers. On the commercial front, the drug enjoyed a boost in recent years because of its application in fighting the coronavirus.

Still, 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 report (PDF) for 2022, Roche said its primary patents 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 Biogen weighs strategic options for its biosimilar group.  

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

Biogen’s biosim franchise generated $751 million in 2022, a 10% decline from 2021. In the first half of the year, the group generated $387 million. 

Biogen licensed the Actemra biosimilar from Bio-Thera Solutions, which developed the drug. Biogen has claimed worldwide rights, excluding China.