Welcome to our dedicated page for Alvotech news (Ticker: ALVO), a resource for investors and traders seeking the latest updates and insights on Alvotech stock.
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.
The FDA has accepted a Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab), jointly announced by Dr. Reddy's Laboratories and Alvotech. AVT03 aims to treat osteoporosis in post-menopausal women and prevent bone complications in cancer patients.
Under a License and Supply Agreement from May 2024, Alvotech will handle development and manufacturing, while Dr. Reddy's will manage registration and commercialization in applicable markets, including the U.S. Upon FDA approval, AVT03 will be available in two formulations: a 60 mg/1 mL single-dose prefilled syringe and a 120 mg/1.7 mL single-dose vial.
Alvotech (NASDAQ: ALVO) and Dr. Reddy's announced that the FDA has accepted their 351(k) Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab). The biosimilar aims to treat osteoporosis in post-menopausal women and prevent bone complications in cancer patients.
Under their License and Supply Agreement from May 2024, Alvotech will handle development and manufacturing, while Dr. Reddy's will manage registration and commercialization in key markets, including the U.S. Upon FDA approval, AVT03 will be available in two formulations: a 60 mg/1 mL single-dose prefilled syringe and a 120 mg/1.7 mL single-dose vial.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has announced its participation in the Barclays 27th Annual Global Healthcare Conference in Miami, Florida from March 11-13, 2025.
The company's founder, chairman and CEO Robert Wessman, along with management team members, will conduct one-on-one meetings during the event. Additionally, Alvotech will participate in a fireside chat on March 12, 2025, from 9:30-9:55 am EDT. The session will be available via audio webcast in the Events Section of Alvotech's Investor Portal, with the recording accessible for 90 days post-event.
Alvotech and Teva Pharmaceuticals announced that the FDA has accepted for review Biologics License Applications (BLA) for AVT05, their proposed biosimilar to Simponi® and Simponi Aria® (golimumab). This marks the first U.S. BLA acceptance for a golimumab biosimilar candidate, with FDA review expected to complete in Q4 2025.
The announcement follows positive top-line results from clinical studies in April 2024 for rheumatoid arthritis patients and pharmacokinetic studies in November 2023. This development is part of a strategic partnership between Alvotech and Teva, which now encompasses nine biosimilar products.
The partnership has already achieved FDA approval for two other biosimilars: SIMLANDI® (adalimumab-ryvk) in February 2024 and SELARSDITM (ustekinumab-aekn) in April 2024. SIMLANDI launched in May 2024, while SELARSDITM is planned for U.S. market entry in February 2025.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has scheduled its full year 2024 financial results announcement for March 26, 2025, after U.S. markets close. The company will host an analyst conference call on March 27, 2025, at 8:00 am ET (12 noon GMT).
A live audio webcast of the conference call will be available to investors, media, and the public. The webcast recording will remain accessible for 90 days after the event on Alvotech's investor website. Additionally, the company will host a local investor event in Icelandic at Sæmundargata 15-19, Reykjavik, on March 27, 2025, at 4:00 pm GMT.
Teva Pharmaceuticals and Alvotech have announced the U.S. availability of SELARSDI™ (ustekinumab-aekn), a biosimilar to Stelara®. The FDA approved SELARSDI in October 2024 for treating psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis in adults and certain pediatric patients.
SELARSDI is the second biosimilar launched under the Teva-Alvotech partnership, which includes nine products. The FDA has provisionally determined SELARSDI's interchangeability with Stelara® following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025.
The drug is available in four presentations: 45 mg/0.5 mL and 90 mg/mL in prefilled syringes, 45 mg/0.5 mL in single-dose vials for subcutaneous injection, and 130 mg/26 mL for intravenous infusion. Alvotech develops and manufactures the product, while Teva handles U.S. commercialization.
Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to Eylea® (aflibercept). The regulatory approval process is expected to complete in Q4 2025.
AVT06 is designed to treat eye disorders that can lead to vision loss or blindness. In January 2024, Alvotech reported positive top-line results from a confirmatory clinical study comparing AVT06 with Eylea®, meeting its primary endpoint and demonstrating therapeutic equivalence and comparable safety.
Additionally, Alvotech is developing AVT29, a biosimilar candidate for Eylea® HD (8 mg), with Teva holding U.S. commercialization rights. Eylea® sales (low dose and HD combined) in the U.S. reached $4.77 billion in 2024.
Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals announced that the FDA has accepted for review Biologics License Applications (BLA) for AVT05, their proposed biosimilar to Simponi® and Simponi Aria® (golimumab). This marks the first U.S. BLA filing acceptance for a golimumab biosimilar candidate, with FDA review expected to complete in Q4 2025.
The announcement follows positive top-line results from a confirmatory clinical study in April 2024 comparing AVT05 with Simponi® in rheumatoid arthritis patients, and successful pharmacokinetic study results from November 2023. This development is part of a strategic partnership between Alvotech and Teva, which now includes nine biosimilar products. The partnership has already achieved FDA approval for two other biosimilars: SIMLANDI® (adalimumab-ryvk) in February 2024 and SELARSDITM (ustekinumab-aekn) in April 2024.
Alvotech (NASDAQ: ALVO) announced its addition to the Nasdaq Biotechnology Index (NBI), effective December 23, 2024, as part of the index's annual reconstitution. The inclusion reflects Alvotech's meeting of eligibility requirements, including minimum market capitalization and average daily trading volume criteria. The NBI comprises Nasdaq-listed companies classified as Biotechnology or Pharmaceuticals according to the Industry Classification Benchmark and is calculated using a modified capitalization-weighted methodology.
Senti Biosciences (SNTI) announced the first patient dosing in a clinical trial of SN301A for hepatocellular carcinoma (HCC) in mainland China, in collaboration with Celest Therapeutics. The trial aims to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of SN301A, a CAR-NK cell therapy utilizing Senti's Gene Circuit platform, in patients with advanced GPC3-expressing HCC across multiple dose cohorts.
Celest is leading the clinical development, operations, and manufacturing in China, with Senti Bio providing technical and strategic input. The study will assess adverse events, dose-limiting toxicities, and efficacy using standard liver cancer response criteria. The collaboration may expand to Hong Kong, Macau, and Taiwan, while Senti Bio retains rights outside these regions.