Interchangeable high-concentration Humira approved in US

For the first time, pharmacists in the US will be able to substitute a cheaper biosimilar version when they receive a prescription for AbbVie’s high-concentration formulation of Humira, without the intervention of a physician.

That is because Alvotech and commercial partner Teva have claimed approval for their Simlandi biosimilar of Humira (adalimumab), which includes the first and so far only fully interchangeable version of the 40 mg/0.4 mL formulation.

The formulation accounts for around 88% of prescriptions of the immunology drug, according to sales data from Symphony cited by Teva, which said it will launch the new biosimilar "imminently."

Teva and Alvotech reckon that interchangeability will unlock growth in the market for biosimilar Humira, which has developed relatively slowly, despite the approvals of several products in the 12 months or so since the blockbuster brand lost market exclusivity last year.

Sales of Humira – used to treat a long list of diseases, including rheumatoid arthritis, psoriasis, and inflammatory bowel disease – fell by a third to $14.4 billion last year, having been over $20 billion before the drug lost patent protection in Europe in 2018. More than $12 billion of 2023 sales came from the US market.

Non-interchangeable biosimilars, which have to be specified by the prescriber, have been launched in the US by Amgen, Biocon, Celltrion, Coherus, Fresenius Kabi, Sandoz, and Organon/Samsung, while Boehringer Ingelheim’s Cyltezo and Pfizer's Abrilada are interchangeable, but only for the lower concentrations (40 mg/0.8 mL or 20 mg/0.4 mL) of Humira.

Most are, however, working to get interchangeable status for their biosimilars, and three of them – Organon/Samsung Bioepis’ Hadlima, Sandoz’ Hyrimoz, and Celltrion’s Yuflyma – already have approval for high-concentration versions.

It’s also worth noting that most (47), but not all, US states allow interchangeable biosimilars to be substituted for the brand without prescriber involvement, and around 40 states require that patients be told of the plan to switch before the drug is dispensed.

Simlandi reaches the market well after its rivals, mainly a result of delays caused by manufacturing compliance issues at an Alvotech facility, but Teva and Alvotech believe that it will make quick gains this year and next as payers in the US renegotiate their formularies, thanks to its interchangeable exclusivity at the high concentration.

“Biosimilars create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients,” said Dr Eric Hughes, Teva’s chief medical officer.

“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 US.”