FDA Approves Tofidence

Wed Oct 11 10:26:47 CST 2023

Sept. 29, 2023, the U.S. Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Actemra. The Tofidence intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

Tofidence is the first tocilizumab biosimilar approved in the United States. Biosimilars are biologic products that have been demonstrated to have equivalent efficacy and comparable safety as the approved reference product, with the advantage that they may offer cost savings and promote expanded and sustainable access to therapies. Spending on therapies for autoimmune diseases has consistently increased by 10%–25% each year over the past decade1. Since biosimilar entry in the US, medicines with biosimilar competition have experienced greater patient adoption equaling more than 150 million days of patient therapy.

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“The approval of Tofidence in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics.”

Biogen and Bio-Thera entered into a commercialization and license agreement for Tofidence (BAT1806/BIIB800) in April 2021. Developed by Bio-Thera, Tofidence will be commercialized by Biogen in the United States. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to Tofidence in all countries excluding China (including Hong Kong, Macau and Taiwan). Biogen is currently evaluating the potential launch timeline for Tofidence in the U.S.

The FDA approval of Tofidence was based on a comprehensive analytical, non-clinical and clinical data package submitted by Biogen to the FDA in Sept 2022. Extensive analytical characterization of the structural, physicochemical, and biological properties of Tofidence was conducted and supports biosimilarity with the reference product. Additionally, a randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety and immunogenicity of Tofidence with both the US and EU reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm parallel phase III study compared Tofidence with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with rheumatoid arthritis inadequately controlled by methotrexate. The totality of evidence demonstrated Tofidence is a biosimilar of the reference biologic.

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About Tofidence (tocilizumab)

Tofidence (tocilizumab), is a treatment developed as a biosimilar to the reference product Actemra. Tofidence is indicated for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.


The FAI climbed 5.9 percent year-on-year in the first 11 months of 2018, quickening from the 5.7-percent growth in Jan-Oct, the National Bureau of Statistics (NBS) said Friday in an online statement.

The key indicator of investment, dubbed a major growth driver, hit the bottom in August and has since started to rebound steadily.

In the face of emerging economic challenges home and abroad, China has stepped up efforts to stabilize investment, in particular rolling out measures to motivate private investors and channel funds into infrastructure.

Friday's data showed private investment, accounting for more than 60 percent of the total FAI, expanded by a brisk 8.7 percent.

NBS spokesperson Mao Shengyong said funds into weak economic links registered rapid increases as investment in environmental protection and agriculture jumped 42 percent and 12.5 percent respectively, much faster than the average.

In breakdown, investment in high-tech and equipment manufacturing remained vigorous with 16.1-percent and 11.6-percent increases respectively in the first 11 months. Infrastructure investment gained 3.7 percent, staying flat. Investment in property development rose 9.7 percent, also unchanged.