Teva has sights on $12.2 billion Humira market after receiving FDA approval for arthritis injection
Teva has sights on $12.2 billion Humira market after receiving FDA approval for arthritis injection
The Israeli pharma company and Iceland’s Alvotech announced that the SIMLANDI injection has been approved as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis
Israeli pharma company Teva and Iceland’s Alvotech announced that the U.S. Food and Drug Administration (FDA) has approved SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. In 2023, Humira was one of the highest grossing pharmaceutical products in the world, with sales in the U.S. of nearly $12.2 billion.
Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.
SIMLANDI is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA, and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection.
"The approval of SIMLANDI marks the first high-concentration, citrate-free biosimilar to Humira with IC status," said Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer at Teva. "Biosimilars create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients. This approval marks an important milestone for Teva and Alvotech’s partnership to collaborate on seven biosimilars and expand the availability, access, and uptake of biosimilars in the U.S."
In August 2020, Alvotech and Teva entered into a strategic partnership for the exclusive commercialization of five of Alvotech’s biosimilar product candidates, and in August 2023 the partners extended the partnership to include two additional biosimilars and two new presentations of previously partnered products. Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization.
