Alvotech and Teva Announce FDA Approval of SIMLANDI® (adalimumab-ryvk), First Interchangeable, Citrate-Free, High-Concentration Biosimilar to Humira

The U.S. Food and Drug Administration (FDA) approved Alvotech(ALVO.US)And its partnersTeva Pharmaceutical IndustriesThe launch of Simlandi (adalimumab-ryvk), an arthritis injection by TEVA.US.As of the time of writing,Teva Pharmaceutical IndustriesUp over 5%, reported at $13.63;Alvotech Up Over 12% in Pre-Market Trading。

Simlandi is the United StatesAbbVieThe First Citrate-Free, High-Concentration Biosimilar of the Heavyweight Arthritis Treatment Drug Humira.

For 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. It will obtain the interchangeable exclusivity qualification for the 40 mg/0.4ml injection.

As part of the 2020 agreement,Teva Pharmaceutical IndustriesWill become Alvotech's exclusive strategic partner for the commercialization of Simlandi in the United States. Simlandi is the first biosimilar approved under the strategic partnership. This injection is expected to launch soon in the United States and is interchangeable.

Additionally, Alvotech announced on Monday that it has accepted an offer from investors to sell 10,127,132 ordinary shares for approximately $166 million.

The biotechnology company will use the net proceeds from this transaction to support the anticipated biosimilar launch, enhance its production capabilities, and for general corporate purposes and working capital.

These shares are expected to be delivered to investors from the treasury shares previously issued by Alvotech's subsidiary, Alvotech Manco ehf. The transaction will take placeNASDAQConducted on the Iceland Stock Exchange.

Editor: Guo Mingyu