Alvotech develops and manufactures biosimilar medicines for global markets. Company news centers on its approved and marketed biosimilars to Humira, Stelara, Simponi, Eylea and Prolia/Xgeva, along with disclosed candidates for autoimmune disorders, eye disorders, osteoporosis, respiratory disease and cancer.
Recurring updates cover financial results, annual reporting, FDA interactions tied to the Reykjavik manufacturing facility, biosimilar study results such as AVT80, supply and commercialization partnerships, intellectual-property settlements, executive changes and manufacturing-platform developments. Alvotech also reports on global commercial reach through partners across the United States, Europe, Japan, China and other international markets.
Alvotech (NASDAQ: ALVO) has initiated a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab), assessing its pharmacokinetics, safety, and tolerability in healthy adults. The candidate addresses chronic inflammatory diseases, and combined net revenues from Simponi® and Simponi Aria® exceeded $2.2 billion up to October 2022. Alvotech aims to enhance access to affordable biologics through its growing portfolio of eight products targeting various ailments. Regulatory approval for AVT05 is pending.
The FDA has accepted the Biologics License Application (BLA) for AVT04, a proposed biosimilar to Stelara® (ustekinumab), developed by Alvotech and Teva Pharmaceuticals. The regulatory review is expected to complete in the second half of 2023. AVT04 aims to treat inflammatory conditions and has shown therapeutic equivalence in clinical trials. This partnership was formed in August 2020 to commercialize Alvotech’s biosimilar products in the U.S. Both companies are focused on expanding access to cost-effective biosimilar treatments.
Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals announced that the FDA has accepted the Biologics License Application (BLA) for Alvotech’s proposed biosimilar AVT04, a candidate to Stelara® (ustekinumab), intended to treat various inflammatory conditions. The FDA’s review is expected to conclude in the second half of 2023. This development reflects Alvotech's capabilities in biosimilars and aims to enhance patient access to affordable treatments.
Alvotech (NASDAQ: ALVO) has received confirmation from the FDA regarding its license application for AVT02, targeting an approval decision by April 13, 2023. The FDA's review of AVT02 as an interchangeable biosimilar to Humira® is complete, pending a successful facility reinspection scheduled for the first quarter of 2023. Alvotech anticipates the launch of AVT02 in the U.S. on July 1, 2023, having already launched it in 17 international markets and secured marketing approval in 35 countries.
Alvotech (NASDAQ: ALVO) has completed a private placement of subordinated convertible bonds totaling approximately US$70 million, correcting an earlier announcement of US$59.7 million. The offering consists of two tranches with differing annual payment-in-kind coupon rates: 15% for Tranche A (ISK denominated) and 12.5% for Tranche B (USD denominated). Proceeds will primarily replace a US$50 million loan from Alvogen, eliminating associated share warrant rights. The bonds can convert into ordinary shares at a fixed rate of US$10 per share.
Alvotech (NASDAQ: ALVO) has completed a private placement of approximately US$70 million in subordinated convertible bonds, correcting an earlier reported amount of US$59.7 million. The offering includes two tranches: Tranche A, denominated in ISK with a 15% annual payment-in-kind (PIK) coupon, and Tranche B, in USD with a 12.5% PIK coupon. Proceeds will primarily restructure a US$50 million unsecured loan from Alvogen, eliminating associated warrants. Bonds can be converted into shares at US$10 each in 2023 or 2024.
Alvotech (NASDAQ: ALVO) has completed a private placement of approximately US$59.7 million through subordinated convertible bonds. The proceeds will mainly replace a US$50 million unsecured subordinated loan from Alvogen. The bonds will mature in 36 months and bear a 15% annual PIK coupon for the ISK tranche and 12.5% for the USD tranche. Holders can convert these bonds into shares at US$10 per share within specific timeframes. The company aims to strengthen its financial position and streamline its debt obligations.
Alvotech (NASDAQ: ALVO) announced the transition of its shares from the Nasdaq Iceland First North Growth market to the Main Market effective December 8, 2022. This move is expected to enhance visibility, potentially allowing for inclusion in domestic and global indexes. Alvotech is the first dual-listed Icelandic company in both the U.S. and Iceland, having debuted in June 2022. Founder Robert Wessman will ring the Nasdaq Iceland closing bell to celebrate this milestone.
Alvotech (NASDAQ: ALVO) and STADA have expanded the launch of Hukyndra (adalimumab), a high-concentration, citrate-free biosimilar, into Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia. This follows its initial introduction in nine European countries. The partnership aims to enhance access to biologics for autoimmune conditions while leveraging Alvotech's manufacturing capabilities in Iceland. Hukyndra is already approved in the EU, Norway, and other countries, with ongoing reviews in multiple regions, including the U.S.
Nasdaq Iceland has approved Alvotech S.A. for admission to trading on the Nasdaq Iceland Main Market. The shares will transition from the First North Market to the Main Market after the prospectus is passported to Iceland. Alvotech has been listed in the US since June 16, 2022, and will retain the ticker symbol ALVO on the Main Market. The Board of Directors previously approved this transition on August 12, 2022. Alvotech specializes in developing biosimilar medicines, targeting markets worldwide, with a diverse pipeline of eight biosimilar candidates.