Alvotech gets FDA approval for new SIMLANDI process that more than doubles output per batch

What's the deal? Alvotech, the Icelandic biosimilar developer, announced on 20 October 2026 that the US Food and Drug Administration (FDA) approved a new manufacturing process (Process 2.0) for SIMLANDI (adalimumab-ryvk), its biosimilar to Humira (adalimumab), a widely used anti-inflammatory biologic. The approval allows the new process to be used in Alvotech's DSM2 manufacturing suite in Reykjavik, Iceland, and more than doubles the output of drug substance per batch without changing the scale of the upstream manufacturing equipment. Alvotech says the improvement came from targeted process development and successful process validation, with demonstrated comparability to the previously approved process, maintaining product quality, safety and efficacy.

Why it matters: Biosimilars are near-copies of an existing biologic medicine, made to be cheaper and as effective as the original. Being able to make the same amount of drug substance in fewer batches frees up manufacturing capacity for other products in Alvotech's portfolio and gives the company more flexibility to meet growing demand for SIMLANDI, one of its lead commercial products. It follows the FDA's 5 October 2026 approval of a second US commercial manufacturing suite for the drug, which doubled the US supply capacity. Together the two approvals signal that the FDA inspection issues that delayed SIMLANDI's US launch in 2023 are behind the company, and that it can now expand supply for the world's largest adalimumab market.

Read more: Alvotech, 20 October 2026