Latest news
- Business24 May 2022
Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT04 and Reference Product Stelara®
- The confirmatory clinical, safety and efficacy study for AVT04, biosimilar candidate to Stelara® (ustekinumab) met its primary endpoint. - AVT04 (ustekinumab) is part of a broader pipeline of Alvotech’s biosimilars and...
- Business16 May 2022
Alvotech Announces Positive Results from a Pharmacokinetic Similarity Study for AVT04, a Proposed Biosimilar to Stelara®
- Results from pharmacokinetic (PK) similarity study demonstrate bioequivalence of AVT04 (ustekinumab) to the reference product Stelara® Reykjavik, ICELAND (May 16, 2022) – Alvotech Holdings S.A. (“Alvotech”), a global biotech...
- Business11 May 2022
Alvotech and OACB Announce Extraordinary General Meeting to Approve Business Combination
Reykjavik and Los Angeles (May 11, 2022) – Alvotech Holdings S.A. (“Alvotech S.A.”), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, and...
- Business19 April 2022
Alvotech Improves Access to Capital and Streamlines Path to Expected Public Listing on NASDAQ Stock Exchange
Alvotech and Oaktree Acquisition Corp. II establish financing facilities to enhance the company’s capital position and to replace any redeemed capital as part of their proposed merger. Parties agree to...
- Business06 April 2022
Alvotech and STADA pave way to launching HUKYNDRA®(AVT02), a citrate-free, high-concentration biosimilar to Humira® by resolving European patent dispute with AbbVie
Upon launch, HUKYNDRA® will be one of two citrate-free, high-concentration adalimumab biosimilars on the European market. All intellectual-property disputes related to market entry of Alvotech’s AVT02 (adalimumab) in the U.S....
- Business08 March 2022
Alvotech Resolves U.S. Patent and Trade Secret Disputes with AbbVie, Securing U.S. Rights for Alvotech’s Proposed High-Concentration Biosimilar (AVT02) for Humira®
Alvotech expects AVT02 (adalimumab) will be marketed in the U.S., subject to regulatory approval, on July 1, 2023. All ongoing U.S. disputes between AbbVie and Alvotech have been resolved, including...
- Business28 February 2022
FDA Accepts Alvotech’s BLA Supporting Interchangeability for ATV02, a High Concentration, Citrate-Free Biosimilar Candidate for Humira®
Alvotech is the only known company to have both developed a high-concentration biosimilar to Humira and conducted a switching study to support interchangeability. Reykjavik, Iceland (February 28, 2022) — Alvotech...
- Business23 February 2022
Alvotech and Fuji Pharma Expand Partnership for Additional Biosimilar Candidate in Japan
Fuji and Alvotech partnership now covers six proposed biosimilar products. Reykjavik, Iceland & TOKYO, JAPAN (February 23, 2022) — Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical company focused solely on...
- Business02 February 2022
Alvotech Enters Exclusive Global Licensing Agreement with BiosanaPharma for Co-Development of a Proposed Biosimilar (AVT23) to Xolair® (Omalizumab)
Reykjavik, Iceland & Leiden, The NetherlandS (February 2, 2022) — Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients...
- Business18 January 2022
Alvotech Upsizes Oversubscribed PIPE Transaction to Approximately $175 Million
Reykjavik (January 18, 2022) — Alvotech Holdings S.A. (“Alvotech”), a leading global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, and Oaktree Acquisition...
- Business10 January 2022
JAMP and Alvotech Announce Canadian Approval of SIMLANDI™, a High-Concentration Biosimilar to Humira®, Providing Access to Previously Unavailable Versions in Canada
Health Canada rules that 40 mg/0.4 mL and 80 mg/0.8 mL presentations of SIMLANDI™ are not subject to the statutory stay, clearing the way for the launch in the Canadian...
- Business16 December 2021
AVT02 Approved for Use in European Union
Alvotech received approval for AVT02 (100 mg/mL), the company’s high concentration biosimilar to Humira® (adalimumab), from the European Commission (EC) on Nov. 15. The centralized marketing authorization in the European...
- Business07 December 2021
Alvotech and Oaktree Acquisition Corp. II Announce Merger Agreement to Create a Leading Publicly-Traded Global Biopharmaceutical Company
- Alvotech is a leading pure play biosimilar platform focused on the development and manufacture of high-quality biosimilar medicines for global markets. Biosimilars are therapeutic equivalents to biologics, a rapidly...
- Business08 October 2021
Alvotech beats back Abbvie's trade secrets lawsuit
U.S. Federal Judge Grants Alvotech’s Motion to Dismiss AbbVie’s lawsuit alleging misappropriation of trade secrets
- Business20 September 2021
Alvotech Provides Update on FDA Action Regarding AVT02, Proposed High-Concentration Biosimilar to Humira® (adalimumab)
Reykjavik, Iceland (September 20, 2021) – Alvotech, a multinational biopharmaceutical company focused on the development and manufacturing of high quality biosimilars for global markets, today announced that the FDA is...
- Business17 September 2021
Alvotech Welcomes Positive CHMP Opinion for AVT02, a Proposed Biosimilar to Humira®
Alvotech, today welcomed the positive opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a...
- Business13 September 2021
The Future of Innovation. Alvotech and the University of Iceland hosted a conference on how academia and industry can create value together
A good collaboration between the University, scientific community and business world is crucial for development and innovation. The partnership of Alvotech and the University of Iceland, has contributed to the...
- Business10 September 2021
Alvotech Announces Positive Top-line Results for Switching Study Between Proposed Biosimilar AVT02 and Humira®
Alvotech, today announced top-line results from a randomized study in patients that demonstrate bioequivalence of repeated switches between administration of Humira® (adalimumab) and Alvotech’s high-concentration biosimilar candidate, AVT02 (100 mg/mL)...
- Business06 July 2021
Alvotech initiates clinical studies for AVT04, a proposed biosimilar to Stelara® (ustekinumab)
Approximately 530 participants will be enrolled in a comparative, confirmatory efficacy and safety study for AVT04 in plaque psoriasis, across Central and Eastern European countries. AVT04 Pharmacokinetic (PK) comparability...