[press_quote] 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.
