Interchangeable Humira Biosimilar Simlandi Joins Market Battle with Unique High-Concentration Formula

1. Teva and Alvotech have won FDA approval for their interchangeable Humira biosimilar, Simlandi (adalimumab-ryvk).
2. Simlandi is the first high-concentration, citrate-free, and interchangeable Humira biosimilar in the United States.
3. The drug is designed to treat various conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and others.
4. Simlandi's interchangeability allows pharmacy-level substitution without consulting the prescriber, similar to switching from a branded drug to a generic.
5. After resolving manufacturing issues at Alvotech's Reykjavik, Iceland facility, the partners plan to launch Simlandi "imminently".
6. Simlandi will compete with other Humira biosimilars, including Amgen's Amjevita, Celltrion's Yuflyma, and Boehringer Ingelheim's Cyltezo, which is also an interchangeable biosimilar.
7. The FDA approval follows a prolonged regulatory process involving multiple rejections due to manufacturing concerns.
8. Although biosimilars in the U.S. have seen limited market share growth, Alvotech CEO Robert Wessman believes Simlandi could influence further biosimilar conversion due to its unique high-concentration interchangeable status.
9. Alvotech and Teva will focus on differentiating Simlandi's features, including its high-concentration formulation, interchangeability, and marketing strategy.