Alvotech Shares Rise Premarket After Humira Biosimilar Approval
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 26, 2024 06:47 ET (11:47 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
5 Undervalued Stocks to Buy to Play a Little Defense
-
Markets Brief: AI Leaders Excel In Earnings Season So Far
-
What History Tells Us About the Fed’s Next Move
-
What’s Happening In the Markets This Week
-
Alphabet’s New Dividend: What Investors Need to Know
-
Going Into Earnings, Is Palantir Stock a Buy, a Sell, or Fairly Valued?
-
Going Into Earnings, Is Eli Lilly Stock a Buy, a Sell, or Fairly Valued?
-
What’s the Difference Between the CPI and PCE Indexes?
-
Paramount Earnings: CEO Has Gone, For-Sale Sign Is Up; Good Results Would’ve Been Nice to Learn
-
After Earnings, Is Tesla Stock a Buy, a Sell, or Fairly Valued?
-
After Earnings, Is GE Aerospace Stock a Buy, a Sell, or Fairly Valued?
-
3 Good Stocks to Buy with Your Tax Refund in 2024 (Or with Any Extra Money)
-
SoFi Earnings: Revenue Growth Slows on Lower Loan Growth and Higher Credit Costs
-
Tesla: Full Self-Driving Approval In China Supports Our View for Deliveries Growth In 2024
-
Philips Earnings: Firm Reaches $1.1 Billion Settlement Agreement
-
AbbVie Earnings: Next-Generation Immunology Drugs Help Offset Humira Biosimilar Pressure