Alvotech to Manufacture Interchangeable Humira Biosimilar for Teva and Quallent

Alvotech will manufacture its high-concentration interchangeable biosimilar of AbbVie’s Humira (adalimumab) for Quallent Pharmaceuticals. This is part of the Alvotech’s U.S. commercialization agreement with Teva. The biosimilar will be distributed under Quallent’s private label and will be available in June through Evernorth’s Accredo specialty pharmacy.

Last week, Evernorth announced it would be offering a private label Humira biosimilar. The interchangeable biosimilar will be available for patients for $0 out of pocket for eligible patients of its specialty pharmacy Accredo. The $0 copay is offered through Quallent's copay assistance program. This program is estimated to save individual patients around $3,500 on average per year, Evernorth officials said in a news release.

Related: Evernorth to Offer Private Label Humira Biosimilar

The FDA approved Alvotech’s biosimilar on Feb. 24, 2024, as a high-concentration interchangeable biosimilar to Humira, to treat adults with 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.

This is the first high-concentration, citrate-free biosimilar to Humira granted an interchangeability status by the FDA and Alvotech will have interchangeable exclusivity for the 40mg/0.4mL strength.

Related: FDA Approves Simlandi, Third Interchangeable Humira Biosimilar

The FDA also approved Alvotech's branded product Simlandi in February, making it the 10th Humira biosimilar to be available. Teva is the U.S. commercial partner for Simlandi, which is the first interchangeable high-concentration, citrate-free biosimilar to Humira.

While both low-concentration and high-concentration strength biosimilars of Humira, nearly 88% of U.S. prescriptions for adalimumab are for the high-concentration presentation. Simlandi will launch on May 20, 2024.

The majority of Teva's biosimilar products will come from strategic partnerships, including Alvotech. A Teva spokesperson said this allows the company to allocate capital across the business. “The partnership model positions Teva for success in biosimilars, enabling us to leverage our commercial presence and experience across markets,” the spokesperson said.

In August 2020, Alvotech and Teva entered into a strategic partnership for the 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.

Under the partnership, Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization. The Teva spokesperson said the agreement with Quallent provides an additional opportunity to offer a high-concentration interchangeable adalimumab to patients who need them.