Game-Changer: FDA Grants Approval to TOFIDENCE™, a Biosimilar of ACTEMRA® by Bio-Thera Solutions

Bio-Thera Solutions, Ltd. has announced that its partner, Biogen, received FDA approval for TOFIDENCE (tocilizumab-bavi), an intravenous formulation biosimilar referencing ACTEMRA. This marks Bio-Thera’s first FDA-approved product in the United States and the first biosimilar developed and manufactured by a Chinese pharmaceutical company approved in the U.S.

TOFIDENCE is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. The FDA approval was based on comprehensive analytical, non-clinical, and clinical data submitted by Biogen to demonstrate biosimilarity with the reference product.

About TOFIDENCE (tocilizumab)

TOFIDENCE (tocilizumab) is a biosimilar medication developed as an alternative to the reference product ACTEMRA. It is approved for the treatment of several inflammatory autoimmune conditions, including:

  1. Moderate to Severe Rheumatoid Arthritis: TOFIDENCE can be used to manage the symptoms of rheumatoid arthritis when the disease is moderate to severe. It helps reduce inflammation and alleviate joint pain and swelling associated with this condition.
  2. Polyarticular Juvenile Idiopathic Arthritis: This medication is also indicated for the treatment of polyarticular juvenile idiopathic arthritis, a type of arthritis that affects children and adolescents and involves inflammation in multiple joints.
  3. Systemic Juvenile Idiopathic Arthritis: TOFIDENCE can be used to treat systemic juvenile idiopathic arthritis, another form of arthritis primarily affecting children. It is characterized by arthritis symptoms and systemic inflammation, including fever and rash.

Tocilizumab, the active ingredient in TOFIDENCE, works by binding to interleukin-6 (IL-6) receptors in the body. IL-6 is a cytokine involved in the inflammatory process. By blocking IL-6 receptors, TOFIDENCE helps reduce inflammation and alleviate the symptoms associated with these autoimmune conditions.

It’s important to note that TOFIDENCE is a biosimilar, which means it is highly similar to the reference product ACTEMRA in terms of quality, safety, and efficacy. Biosimilars are designed to provide a more affordable treatment option while maintaining the same therapeutic effect as the reference product.

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