Teva and Alvotech Announce SIMLANDI® (adalimumab-ryvk) Injection Now Available in the U.S.

Core Viewpoint - Teva Pharmaceuticals and Alvotech have launched SIMLANDI, the first interchangeable high-concentration, citrate-free biosimilar to Humira in the U.S. for various autoimmune conditions, aiming to provide cost-effective treatment options and improve patient access [1][2][3] Company Overview - Teva Pharmaceutical Industries Ltd. is a global leader in pharmaceuticals with a focus on generics and innovation, employing 37,000 people across 58 markets [5] - Alvotech specializes in the development and manufacture of biosimilar medicines, aiming to be a global leader in the biosimilar space with a pipeline of eight disclosed candidates [6][7] Product Details - SIMLANDI (adalimumab-ryvk) is approved by the FDA for multiple indications including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis [1][8] - The product is notable for being the first high-concentration, citrate-free biosimilar to Humira with interchangeability exclusivity for the 40mg/0.4mL injection, addressing the majority of U.S. prescriptions for adalimumab, which are for high-concentration presentations [2][3] Strategic Partnership - Teva and Alvotech formed a strategic partnership in August 2020 for the exclusive commercialization of Alvotech's biosimilar candidates, which has since expanded to include additional products [3] - The partnership allows Alvotech to focus on development and manufacturing while Teva leverages its extensive sales and marketing infrastructure for commercialization in the U.S. [3] Market Impact - The launch of SIMLANDI is expected to create cost-saving opportunities across the healthcare system, contributing to reduced inflationary pressure for healthcare providers and patients [2][3] - Teva is committed to bringing six additional biosimilars to market by 2027, indicating a strong pipeline and focus on expanding its biosimilar offerings [2]