Alvotech moves to bring its Humira biosimilar to US market
Hot on the heels of a US Food and Drug Administration (FDA) approval for Alvotech and Teva Pharmaceuticals’ Simlandi (adalimumab-ryvk), Alvotech has announced a long-term agreement with a strategic partner to increase US market access to the Humira (adalimumab) biosimilar. The long-term agreement will see increased access of Simlandi, a biosimilar to AbbVie’s Humira, in the US market.
Alvotech did not name the stratetic partner in its 19 April press release. The agreement, which was signed under consensus with Teva, will not alter the multi-product commercialisation partnership between the two companies, with Teva continuing the commercialisation of Simlandi in the US.
In July 2023, the two companies stepped up their collaborative partnership by boosting Teva’s catalogue with two new biosimilars. The agreement saw Teva increasing its involvement in manufacturing and quality control at Alvotech’s manufacturing facility.
As per the companies, Simlandi, a tumour necrosis factor (TNF) blocker, is the first available interchangeable, citrate-free, and high-concentration formulation biosimilar to AbbVie’s Humira.
Humira is approved to treat juvenile idiopathic arthritis and rheumatoid arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa, and adult uveitis.
Intent on toppling Humira’s 20-year reign, Amgen’s Amjevita (adalimumab) became the first Humira biosimilar to break into the market in February 2023, with seven other FDA-approved biosimilars following suit later that year. At that time, GlobalData analyst Cyrus Fan said the US market for biosimilars is “notably underdeveloped” and “lagging behind Europe,” said. The primary culprit behind these delayed market entries are patent disputes, he added.
Fan anticipated the price tags for both Humira and its biosimilars to fall over time as more biosimilars look to gain their share of the US market. According to GlobalData’s consensus forecasts, Simlandi is expected to generate global sales of $328m in 2030. Sales of Humira, which amounted to $21.6bn in 2022, are projected to drop as more biosimilars enter the market.
Alvotech is a biotech focused solely on the development and manufacturing of biosimilars. In October 2023, the company signed an exclusive licensing agreement with Kashiv Biosciences to develop AVT23, a biosimilar to Roche and Novartis’ monoclonal antibody Xolair (omalizumab). In the same month, however, the FDA rejected Alvotech’s biologics licence application (BLA) for AVT04, a Johnson & Johnson’s (J&J) Stelara (ustekinumab) biosimilar, citing issues with the company’s manufacturing facility in Reykjavik, Iceland.
April 22, 2024
