By Colin Kellaher

Shares of Alvotech rose sharply in premarket trading after the biotechnology company won a key U.S. regulatory approval for its biosimilar to the blockbuster anti-inflammatory drug Humira and agreed to raise $166 million in a stock sale.

Alvotech and partner Teva Pharmaceuticals late Friday said the U.S. Food and Drug Administration approved its Simlandi injection as an interchangeable biosimilar to AbbVie's 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.

An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are substituted for brand-name drugs.

Alvotech and Teva said Simlandi is the first high-concentration, citrate-free biosimilar to Humira to receive interchangeability status from the FDA, adding that the biosimilar qualifies for interchangeable exclusivity for the 40mg/0.4ml injection.

Under a 2020 agreement, Alvotech handles development and manufacturing of its biosimilars, while Teva is responsible for U.S. commercialization. The companies said they expect to launch Simlandi in the U.S. imminently with interchangeability designation.

Alvotech also said it agreed to sell more than 10.1 million shares at $16.41 apiece, adding that it will use the proceeds to bolster its production capacity and support biosimilars launches.

Alvotech's U.S.-listed shares, which closed Friday at $16.03, were recently up more than 12% to $18 in premarket trading.

Write to Colin Kellaher at

(END) Dow Jones Newswires

02-26-24 0647ET