Farmak International Confirms Bioequivalence for 10 mg Tofacitinib, UK Filing on Track
Farmak International announced that its 10 mg immediate-release tofacitinib tablet met all European Medicines Agency (EMA) bioequivalence requirements, completing the clinical module needed for a generic application under Article 10(1).
With bioequivalence proven, we can now finalize the dossier, proceed with its regulatory submission, and scale up the manufacturing upon its approval so that our partners have stock available
Pavlo Savenko Launch Management Director, Farmak International
Therapeutic scope (originator-matched)*
Subject to the final label granted in each market, Farmak International’s product will reference the EU indications of the originator Xeljanz® (tofacitinib), currently including:
• Rheumatoid arthritis – moderate to severe, in combination with methotrexate (MTX) or as monotherapy for adults intolerant to MTX
• Psoriatic arthritis – active PsA in adults with inadequate response to disease-modifying antirheumatic drugs
• Ulcerative colitis – moderate to severe active UC in adults who have failed conventional therapy or biologics
• Axial spondyloarthritis (ankylosing spondylitis) – active disease in adults with inadequate response to standard therapy
• Juvenile arthritis – polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients aged ≥ 2 years
Any indications still protected by second-medical-use patents will be excluded from the initial label in line with EU “skinny-label” rules; they can be reinstated once the patents expire.
Xeljanz® is a registered trademark of Pfizer Inc., unaffiliated with Farmak International.
Key next steps
• Q3 2025 – Planned dossier submission in the United Kingdom
• Planned market expansion includes priority submissions across Asian and MENA regions, with timelines aligned to upcoming regulatory milestones.
Competitive advantages
• Regulatory predictability – CMC, stability, and GMP-validation sections already in compilation, enabling an on-schedule EU review
• Market relevance – Global moving-annual-total sales for Xeljanz® (tofacitinib) reached ≈ US $3 billion in 2024, rising at about 11 % compound annual growth since 2021 (see Business Research Company market report).
Partner enquiries
bd@farmak.ch
About Farmak International
Farmak International, headquartered in Switzerland and part of the Farmak Group, directs global strategy and portfolio development for one of Europe’s fastest-growing pharmaceutical networks. Tracing its roots to Ukraine (est. 1925), Farmak Group supplies high-value generics and complex injectables to more than 60 countries.
This release contains forward-looking statements about regulatory timelines and commercial plans. Actual results may differ due to regulatory decisions, market conditions or other factors beyond the company’s control.
