Bio-Thera and STADA Expand Biosimilars Alliance to Tocilizumab
The biosimilars race in Europe just got a major boost. Bio-Thera Solutions andSTADA 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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