Alvotech ALVO
Alvotech (Nasdaq: ALVO) is an immunology/inflammation drug developer. Its lead program, SIMLANDI (adalimumab-ryvk), is marketed for Humira (adalimumab) biosimilar; autoimmune disease.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| SIMLANDI (adalimumab-ryvk) | Humira biosimilar | antibody | Approved |
Recent results and decisions
- Oct 20, 2026approval FDA approved a new manufacturing process for SIMLANDI that more than doubles drug substance output per batch.
The FDA approval allows Alvotech to introduce Process 2.0 for the manufacture of adalimumab drug substance in its DSM2 manufacturing suite in Reykjavik, Iceland.
Filing - Oct 20, 2026approval FDA approves new manufacturing process for SIMLANDI® that more than doubles drug substance output per batch.
The FDA approval allows Alvotech to introduce Process 2.0 for the manufacture of adalimumab drug substance in its DSM2 manufacturing suite in Reykjavik, Iceland.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other approved immunology/inflammation companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.