Formycon (FYB) Jefferies Global Healthcare Conference 2026 summary

Strategic focus and market positioning

• Dedicated exclusively to biosimilar development, leveraging a team of 200+ experts in Munich.

• Portfolio includes seven biosimilar assets across diverse indications, with three already launched (Lucentis, Stelara, Eylea).

• Emphasizes global expansion, targeting not only Europe and the U.S. but also MENA, LATAM, and APAC regions.

• Shifted partnering strategy to regional and semi-exclusive deals, leveraging local expertise and competition.

• Focuses on innovation in delivery devices and operational excellence to maintain competitiveness.

Market trends and regulatory environment

• Biosimilar market potential is expanding as more biologics lose exclusivity, with $200 billion in originator volume expected to open up.

• Regulatory changes by FDA and EMA reduce development barriers, making niche biosimilars more attractive.

• Over 50% of originator products losing exclusivity are not yet covered by biosimilars, indicating strong demand.

• U.S. market dynamics are increasingly favorable, with other regions gaining relevance for growth.

Pipeline and product updates

• Three biosimilars (Lucentis, Stelara, Eylea) are now on the market, with Eylea recently launched in Europe and U.S. launch planned for Q4.

• KEYTRUDA biosimilar completed phase I/PK study; FDA filing planned, with approval targeted for 2027–2028.

• DUPIXENT biosimilar (FYB208) is preparing for clinical entry, with monitoring of potential exclusivity extensions by the originator.

• Lucentis biosimilar was relaunched in the U.S. by Sandoz, with early signs of market share recovery.

• Otulfi (FYB202) partnership with Fresenius Kabi secured a major U.S. federal buyer, potentially generating up to €140 million in revenues over four years.