Roche’s primary patents for Actemra/RoActemra (tocilizumab) have already expired in major markets, including Europe and the US. In September 2023, the FDA approved Tofidence (tocilizumab-bavi, BIIB00) as the first biosimilar referencing the IL-6 receptor antagonist tocilizumab for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Tofidence is the first tocilizumab biosimilar to win FDA approval and also represents Bio-Thera’s entry into this market, and the company is favourably positioned for monetization of the biosimilar in the US, says GlobalData, a leading data and analytics company.

The attractiveness of Roche’s blockbuster as a target for biosimilar developers mirrors the patterns seen with other highly successful blockbuster drugs such as AbbVie’s Humira (adalimumab) and Amgen’s Enbrel. Tofidence was originally developed by Bio-Thera and will be commercialized by Biogen on a global scale (excluding China, which includes Hong Kong, Macau, and Taiwan).

Momna Ali, Healthcare Analyst at GlobalData, comments: “Tofidence’s regulatory milestone is the outcome of a partnership between Biogen and Bio-Thera. The partnership represents a strategic move from Bio-Thera in the biosimilars market, considering that Actemra/RoActemra was a weighty revenue source for Roche, with global sales surging to nearly $4.0 billion in 2021, according to GlobalData’s Sales and Forecast database.’’

GlobalData’s report on “Rheumatoid Arthritis: Global Drug Forecast and Market Analysis to 2029,” reveals that the US holds the dominant position in the 8MM, (US, 5EU, Japan, and Australia) in the RA market.

According to the report, in 2019, approximately 1.6 million cases of RA were diagnosed in the US, contributing to total drug sales of approximately $18.7 billion and representing 71.9% of the global market. This market value is expected to grow to $21.2 billion in 2029 at a compound annual growth rate (CAGR) of 1.3% over the forecast period from 2019 to 2029.

Alongside Tofidence, with the approval of tocilizumab biosimilars like Fresenius Kabi’s TYNEE and the emergence of late-stage biosimilar candidates such as Celltrion’s CT-P47, the biosimilars landscape for RA is changing.

Ali concludes: “A combination of events, including biosimilar erosion and anticipated launches of late-stage pipeline agents, are expected to cause Actemra’s sales to decrease at a CAGR of 3.0% from 2019 to 2029 in the US for RA, and tocilizumab biosimilar sales are poised to increase significantly, with sales expected to reach a value of approximately $339.0 million in 2029 in the US for RA, positioning Bio-Thera favorably for monetization in the US.”