Alvotech Stock Price, News & Analysis

Alvotech (NASDAQ: ALVO) and Advanz Pharma announced the EMA accepted a Marketing Authorization Application (MAA) for AVT23, a proposed biosimilar to Xolair (omalizumab), on Oct 6, 2025, the PR states.

The PR notes Alvotech developed AVT23 with Kashiv BioSciences and that Advanz Pharma holds licensed commercial rights in the EEA, UK, Switzerland, Canada, Australia, and New Zealand. The PR also states the UK MHRA accepted an MAA earlier in 2025. The companies frame the acceptance as a regulatory milestone toward broader patient access to omalizumab biosimilar therapy in respiratory and allergic indications.

Alvotech (NASDAQ: ALVO) has received a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, its proposed biosimilar to Prolia® and Xgeva® (denosumab).

Upon approval, the biosimilar will be marketed by STADA Arzneimittel AG and Dr. Reddy's Laboratories SA with semi-exclusive commercial rights in Europe, including Switzerland and the UK. The biosimilar will be available in two formulations: a 60 mg/mL pre-filled syringe and a 70 mg/mL vial, targeting conditions including osteoporosis in postmenopausal women, bone loss in cancer patients, and giant cell tumor of bone.

Alvotech (NASDAQ: ALVO) and Advanz Pharma have announced that the European Medicines Agency's CHMP has recommended marketing approval for Gobivaz®, a proposed biosimilar to Simponi® (golimumab). The biosimilar is intended for treating several chronic inflammatory diseases.

The recommendation covers 50 mg/0.5mL and 100mg/mL dosages in pre-filled syringe and autoinjector forms. The treatment is indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis in adults and juvenile idiopathic arthritis across the EU, Norway, Iceland, and Lichtenstein.

The recommendation follows successful clinical trials, including positive top-line results from a confirmatory study in April 2024 and a pharmacokinetic study in November 2023.

Alvotech (NASDAQ: ALVO) has secured marketing approval from the Japanese Ministry of Health, Labor and Welfare for three new biosimilars through its partner Fuji Pharma. The approved products include: AVT03 (biosimilar to Ranmark®/denosumab), AVT05 (first-to-market biosimilar to Simponi®/golimumab), and AVT06 (biosimilar to Eylea®/aflibercept).

These approvals follow Alvotech's successful launch of its Stelara® biosimilar in Japan last year. The company's partnership with Fuji Pharma, established in 2018, includes rights to two additional biosimilar candidates under development, bringing their total collaboration to six products.

Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference in New York from September 8-10, 2025.

The company will conduct investor meetings on September 9, followed by a fireside chat featuring Dr. Balaji Prasad, Chief Strategy Officer, on September 10 at 10:45 am EDT. The fireside chat will be publicly accessible via webcast on Alvotech's investor relations website, with a 90-day replay period available after the event.

Alvotech (NASDAQ: ALVO) and Advanz Pharma have entered into a supply and commercialization agreement for AVT10, Alvotech's biosimilar candidate to Cimzia® (certolizumab pegol). The partnership targets the European market, with AVT10 being the only Cimzia® biosimilar under global development.

Cimzia®, a TNF-alpha inhibitor for inflammatory diseases, generated worldwide sales of US$2.3 billion in 2024. The companies plan to launch their first biosimilars in Europe in Q4 2025. This agreement adds to their existing partnership covering biosimilar candidates for more than ten reference biologics.

Alvotech (NASDAQ: ALVO) and Advanz Pharma have received European Commission approval for Mynzepli®, a biosimilar to Eylea® (aflibercept), for treating various retinal diseases. The approval covers all European Economic Area countries and follows positive clinical trial results demonstrating therapeutic equivalence to Eylea®.

The biosimilar is approved for treating multiple eye conditions including wet age-related macular degeneration (AMD), macular edema, diabetic macular edema (DME), and myopic choroidal neovascularization. Notably, Eylea® generated global sales of approximately $9 billion in 2024, with one-third from Europe.

Mynzepli® will be available as a 40 mg/mL solution for injection in both pre-filled syringe and vial formats. The approval is currently under review in other major markets, including the United States and Japan.

Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines, has appointed Patrik Ling as VP of Investor Relations Scandinavia, based in Stockholm. Ling brings over 25 years of life-science industry experience, most recently serving as Senior Equity Analyst at DNB Carnegie where he covered life science companies including Alvotech.

The appointment aligns with Alvotech's strategy to expand its Scandinavian shareholder base and strengthen its position as a leading Nordic life science company. Ling's background spans both pharmaceutical and financial sectors, including roles in marketing, sales, portfolio management, and equity analysis.

Alvotech (NASDAQ: ALVO), a global biotech company, has secured improved terms on its senior secured term loan facility. The company's lenders, including GoldenTree Asset Management, have agreed to reduce interest rates, resulting in estimated savings of $8.2 million in interest payments over the first 12 months.

The facility, which matures in July 2029, will be consolidated into a single tranche with an interest rate of SOFR plus 6.0% per annum, down from previous rates of SOFR plus 6.5% and 10.5%. The total facility balance stands at $1,081 million, with the company maintaining a cash balance of $152 million as of June 25, 2025.