Roche’s primary patents for Actemra/RoActemra (tocilizumab) have already expired in major markets, including Europe and the US. On 29 September 2023, according to a Biogen press release, 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.

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. Bio-Thera’s CEO, Shengfeng Li, emphasised the significance of the company’s achievement: Tofidence not only marks the first FDA approval of a tocilizumab biosimilar in the US, but also represents Bio-Thera’s entry into this market. The milestone is expected to have a substantial impact on their presence and visibility. As Li stated: “The approval of Tofidence is a landmark achievement for Bio-Thera as it marks Bio-Thera’s first FDA approval for a product in the United States.”

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Tofidence’s regulatory milestone is the outcome of a partnership between Biogen and Bio-Thera. The biosimilar was originally developed by Bio-Thera and will be commercialised by Biogen on a global scale (excluding China, which includes Hong Kong, Macau and Taiwan). 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, as stated in GlobalData’s Sales and Forecast database.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Even though RA is a heavily saturated market with respect to available therapies, the number of patients affected by this indication each year has been on the rise. As stated in a report by GlobalData titled Rheumatoid Arthritis: Market Analysis and Forecasts to 2029 – Forecast Update, published in December 2021, within the eight major markets (8MM) – Australia, France, Germany, Italy, Japan, Spain, the UK and the US – the US holds the dominant position. In 2019, approximately 1.6 million cases of RA were diagnosed in the US, contributing to total sales of approximately $18.7 billion, representing 71.9% of the global market.

This US market value is expected to grow to $21.2 billion at a compound annual growth rate of 1.3% from 2019 to 2029. Alongside Tofidence, with the approval of tocilizumab biosimilars such as 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. A combination of events, including biosimilar erosion and anticipated launches of late-stage pipeline agents, is expected to cause Actemra’s sales to decrease at a CAGR of 3.0% from 2019 to 2029 for RA. 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, positioning Bio-Thera favourably for monetisation there.