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  3. Bio Thera And Stada Expand Biosimilars Alliance To Tocilizumab
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  • 25 Aug 2025
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  • News Article

Bio-Thera and STADA Expand Biosimilars Alliance to Tocilizumab

The biosimilars race in Europe just got a major boost. Bio-Thera Solutions and STADA Arzneimittel have extended their partnership to include tocilizumab, a blockbuster immunosuppressant used to treat multiple inflammatory conditions.

What’s New

  • Bio-Thera will handle development, manufacturing, and supply of the biosimilar to Roche’s RoActemra®.
  • STADA will get exclusive commercialization rights across the EU, UK, Switzerland, and select markets.
  • The deal builds on their May 2024 alliance around BAT2506 (golimumab biosimilar to Simponi®), which already has a marketing application under EMA review.

This extension is subject to shareholder approval, but both companies see it as a natural progression.

Why It Matters

  • Market size: RoActemra/Actemra pulled in €2.8 billion in 2024, including ~$700 million from Europe alone—even with biosimilar competition starting.
  • Patient access: Biosimilars like this lower costs, increase availability, and expand treatment options for patients with arthritis and other autoimmune conditions.
  • Strategic scale: For STADA, tocilizumab strengthens its immunology franchise alongside adalimumab and ustekinumab biosimilars, which already lead in several European markets.

Voices from Leadership

  • “STADA is a proven leader in biosimilars. Extending our partnership ensures patients across Europe gain access to affordable tocilizumab,” said Dr. Shengfeng Li, CEO of Bio-Thera.
  • “With €2.8 billion in global sales, tocilizumab is a major opportunity to broaden access and build scale in immunology,” added Ian Henshaw, STADA’s head of global specialty.

Recent Milestones

  • In June 2024, Bio-Thera’s BAT1806 (tocilizumab biosimilar) received EU-wide marketing authorization for 20mg/ml vials.
  • This approval followed a positive EMA opinion for treating multiple arthritic conditions.

The Bigger Picture

This partnership underscores how China-based innovators (Bio-Thera) and European commercialization specialists (STADA) are teaming up to challenge branded biologics head-on.

For patients, it means faster, wider access to high-quality biosimilars. For pharma, it signals the continued erosion of originator monopolies in immunology.

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