Alvotech
🇮🇸Iceland
- Country
- 🇮🇸Iceland
- Ownership
- Public
- Employees
- 999
- Market Cap
- $3.5B
- Website
- http://www.alvotech.com
- Introduction
Alvotech is a biotechnology company, which engages in the development and manufacture of biosimilar medicines. The firm is focusing on the development of its product candidates. It operates through the following geographical segments: Europe, North America, Asia, and Other. The company was founded by Róbert Vilhelm Wessman in 2013 and is headquartered in Luxembourg.
Alvotech application for Simponi biosimilar accepted by EMA
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Alvotech's AVT05 Biosimilar Application Accepted by EMA
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European Medicines Agency Confirms Acceptance of Marketing Authorization
EMA accepts Alvotech's MAA for AVT05, a biosimilar to Simponi®, expected to complete approvals by Q4 2025.
European Medicines Agency Confirms Acceptance of Marketing
Alvotech and Advanz Pharma announce EMA acceptance of AVT05, a proposed biosimilar to Simponi® (golimumab), for marketing authorization, expected to be completed by Q4 2025.
Biosimilars Month in Review: October 2024
New ustekinumab biosimilar approvals for chronic inflammatory diseases, data supporting equivalent safety of etanercept and infliximab biosimilars, and significant cost savings with adalimumab biosimilar.
Alvotech and Teva Announce FDA Approval of Additional SELARSDI Presentation
On October 22, 2024, Alvotech and Teva announced FDA approval for a new SELARSDI (ustekinumab-aekn) presentation, 130 mg/26 mL solution for IV infusion, expanding its label to match STELARA® indications. Thomas Rainey highlighted its potential to aid gastrointestinal disease patients, with a U.S. launch expected in early 2025.
Alvotech and Teva Announce FDA Approval of Additional Presentation for Ustekinumab Biosimilar
Alvotech and Teva announced FDA approval for a new 130 mg/26 mL (5 mg/mL) SELARSDI™ presentation, expanding its label to align with STELARA® indications. This allows for intravenous infusion and supports the U.S. launch in early 2025.
Alvotech and Teva Announce FDA Approval of Additional SELARSDI™ (ustekinumab-aekn) in New IV Infusion Format
Alvotech and Teva announced FDA approval for SELARSDI™ (ustekinumab-aekn) in a new 130 mg/26 mL IV infusion format, expanding its use to match STELARA®'s indications. SELARSDI™, previously approved for subcutaneous injection, is set for U.S. launch in early 2025, aiding gastrointestinal disease patients.
Alvotech, Teva obtain FDA nod for new Selarsdi indication
Alvotech and Teva receive FDA clearance for Selarsdi (ustekinumab-aekn) 130 mg/26 ml, aligning its label with Stelara's indications in the U.S. prior to its 2025 launch. The approval follows successful biosimilar ustekinumab launches in Canada, Japan, and Europe, reflecting the companies' commitment to increasing access to biosimilars globally.
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