Alvotech (ALVO) Goldman Sachs 47th Annual Global Healthcare Conference 2026 summary

Company overview and strategic priorities

• Founded in 2013 with a focus on pure-play biosimilars, investing nearly $2 billion in R&D and manufacturing since inception.

• Built end-to-end in-house R&D and manufacturing capabilities, now commercial in the U.S. as of mid-2024.

• Portfolio includes 30 products, with five launched outside the U.S. and two in the U.S.; three more U.S. launches expected by year-end.

• Global commercial partnerships enable product rollout in up to 90 markets.

• Company at a major inflection point following recent BLA resubmissions in the U.S.

Regulatory updates and product launches

• Recently resubmitted BLAs for biosimilars to Simponi and Eylea ahead of expectations, following a successful FDA inspection.

• Facility issues identified in prior FDA review were addressed with over 200 CAPAs, including changes to syringe lubrication, complaint handling, and environmental monitoring.

• Strong market uptake for Simponi biosimilar in Europe, reaching up to 40% share in some markets.

• Expecting FDA acceptance and potential U.S. launches for three products before year-end, with a six-month review clock.

Pipeline and market opportunities

• Entyvio biosimilar submission accepted by FDA and EMA, targeting a $7.5 billion global market with limited competition and a 12-month approval timeline.

• Simponi and Eylea biosimilars maintain strong commercial prospects, with U.S. launches aligned to settlement timelines in late 2026 or early 2027.

• High-dose Eylea biosimilar development is advanced, with imminent filings outside the U.S. and clinical trials ongoing for U.S. submission.

• Keytruda biosimilar co-developed with Dr. Reddy's, leveraging cost efficiencies by skipping phase III trials.