Home Medizin FDA genehmigt 10. Humira-Biosimilar, einschließlich Austauschbarkeit

FDA genehmigt 10. Humira-Biosimilar, einschließlich Austauschbarkeit

von NFI Redaktion

The US Food and Drug Administration has approved the first interchangeable, high-concentration, citrate-free adalimumab biosimilar, Adalimumab-ryvk (Simlandi).

This marks the tenth adalimumab biosimilar approved by the regulatory agency and the first biosimilar approval in the US market for Icelandic pharmaceutical company Alvotech in collaboration with Teva Pharmaceuticals.

„An interchangeable, citrate-free, high-concentration adalimumab biosimilar has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the US,“ said Robert Wessman, Chairman and CEO of Alvotech, in a press release from the company on February 23.

Adalimumab-ryvk was approved in the European Union in 2021 and in Australia and Canada in 2022.

Adalimumab-ryvk is indicated for adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, Crohn’s disease, plaque psoriasis, hidradenitis suppurativa, and non-infectious intermediate and posterior uveitis, as well as panuveitis. In pediatric patients, it is indicated for polyarticular juvenile idiopathic arthritis in children aged 2 years and for Crohn’s disease in children aged 6 years.

Adalimumab-ryvk is the third Humira biosimilar to receive interchangeability status, allowing pharmacists (depending on local regulations) to substitute the reference product with the biosimilar without involving the prescribing physician. Adalimumab-adbm (Cyltezo), manufactured by Boehringer Ingelheim, and Adalimumab-afzb (Abrilada), manufactured by Pfizer, had previously received interchangeability status; however, they are both interchangeable with the low-concentration formulation of Humira, which reportedly accounts for only about 15% of Humira prescriptions, according to a Goodroot report.

Adalimumab-ryvk is set to launch in the United States „soon,“ as stated in the press release, but specific dates have not been provided. The pricing comparison of the biosimilar to Humira is also unknown at this time. Other adalimumab biosimilars have been introduced to the market with discounts ranging from 5% to 85% off the list price of Humira.

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