Seeking Alpha·United States·Tuesday, October 20, 2026 at 12:02 PM UTC

Alvotech wins FDA nod for new manufacturing process for Humira biosimilar

Translate

Dulan Lokuwithana

Alvotech (ALVO) shares spiked on Tuesday after the U.S. FDA approved a new manufacturing process for Simlandi, a biosimilar the company markets with Teva Pharmaceutical (TEVA), targeting AbbVie’s (ABBV) arthritis therapy Humira (adalimumab).
With the approval, the company will be permitted to add Process 2.0 for the production of adalimumab drug substance in its newly approved DSM2 manufacturing suite in Reykjavik, Iceland, Alvotech (ALVO) stated.
The new process, which has the potential to more than double the drug substance output per batch without impacting product quality, “is a significant achievement that reflects the expertise of our process development and manufacturing teams,” said Chief Operating Officer Joseph McClellan.
In 2024, Teva (TEVA) and Luxembourg-based Alvotech (ALVO) launched Simlandi as an interchangeable biosimilar version of Humira after the blockbuster therapy lost its U.S. market exclusivity a year earlier.

Get the confidence to navigate an uncertain market with free breaking news and stock alerts.

KioskNews shows a cleaned-up reading view extracted from the publisher’s page — the original always lives on their site, not ours.