You came from your AI assistant. Add Equibles to it and ask about this data directly, free.
The company's filings, earnings calls and investor events, most recent first. Search and read these filings from Claude or ChatGPT with the SEC filings MCP server →
Alvotech received FDA approval on October 20, 2026 for a new SIMLANDI® manufacturing process that more than doubles drug substance output per batch while maintaining product quality, safety and efficacy.
Alvotech and Advanz Pharma submitted a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg, described as the first regulatory submission worldwide for that biosimilar. The application is a line extension to Mynzepli’s existing European marketing authorization.
Alvotech and LOTTE Biologics entered a long-term manufacturing partnership for drug substance covering multiple antibody biosimilars at a Syracuse facility with 40,000 liters of bioreactor capacity. Commercial supply requires technology transfer, manufacturing qualification and regulatory approvals.
On October 5, 2026, the U.S. Food and Drug Administration approved Alvotech’s SIMLANDI® to use a second production suite at its Reykjavik facility, doubling drug substance manufacturing capacity for U.S. supply and confirming resolution of inspection-related matters.
