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) announced the appointment of Sarah Tanksley as its new Chief Quality Officer, effective October 14. She succeeds Reem Malki, who stepped down for personal reasons. Tanksley, having previously consulted for Alvotech, brings over 20 years of experience from regulatory agencies like the FDA and the NIH. Her expertise in regulatory compliance and GMP is expected to facilitate a smooth transition and enhance Alvotech's capabilities.
Alvotech focuses on developing biosimilar medicines to serve patients globally.
Alvotech (NASDAQ: ALVO) has launched Hukyndra®, a biosimilar to Humira® (adalimumab), in Switzerland as part of an exclusive partnership with STADA. This new high-concentration, low-volume, citrate-free formulation aims to improve access to biologics for patients in Europe. Hukyndra is available in two presentations and already has approvals in multiple European countries, including the UK and Switzerland. The partnership encompasses six biosimilar candidates, with STADA tasked with commercialization and Alvotech managing development and manufacturing.
Alvotech (NASDAQ: ALVO) announced on September 5, 2022, that it received a Complete Response Letter from the FDA regarding its biosimilar Biologics License Application (BLA) for AVT02, following an inspection of its Reykjavik facility. The FDA cited deficiencies that must be resolved before approval can be granted. CEO Mark Levick expressed commitment to addressing these issues before the Biosimilar User Fee Act goal date in December and anticipates a launch readiness by July 1, 2023. AVT02, a biosimilar to Humira, has been approved in several countries, and its U.S. approval remains pending.
Alvotech (NASDAQ: ALVO) announced the FDA's Complete Response Letter regarding its biosimilar BLA for AVT02, indicating deficiencies found during a March 2022 inspection of its Reykjavik facility. Approval will be contingent upon resolving these issues. CEO Mark Levick expressed optimism about addressing the deficiencies ahead of the December goal date for the BLA. AVT02, comparable to Humira, is already approved in several countries and is anticipated to launch in the U.S. by July 1, 2023.
Alvotech (NASDAQ: ALVO) announced a successful merger with OACB, securing approximately $185 million in gross proceeds. The company reported $40.1 million in revenue for the first half of 2022, a significant rise from $2.0 million during the same period in 2021. Alvotech launched AVT02 (adalimumab) in Canada and Europe, and reported positive results from its clinical pipeline, including biosimilars to Stelara and Xolair. The company plans to transition its Icelandic listing to the Nasdaq Main Market and will hold a business update call on September 1, 2022.
Summary not available.
Alvotech (NASDAQ: ALVO) has initiated a confirmatory patient study for AVT03, a biosimilar candidate to Prolia® and Xgeva®. The study aims to establish clinical similarity in efficacy and safety for treating osteoporosis in postmenopausal women. Prolia® and Xgeva® had combined sales of nearly $5.3 billion in 2021. The multicenter study will involve around 476 women, with results expected after 12 to 18 months. Alvotech, focused on biosimilars, seeks to enhance access to affordable biologic treatments globally.
Alvotech (NASDAQ: ALVO), a global biotech firm focusing on biosimilars, announced participation in two investor conferences in September 2022. The leadership team will engage in fireside chats at Citi’s 17th Annual Biopharma Conference on September 8 at 2:40 pm ET and at Morgan Stanley’s 20th Annual Global Healthcare Conference on September 12 at 2:15 pm ET. A replay of these discussions will be available on their website for 90 days. Alvotech aims to lead in the biosimilar sector with a pipeline of eight candidates addressing various medical conditions.
Alvotech (NASDAQ: ALVO), a global biotech company, has announced participation in two investor conferences in September 2022. The leadership team will engage in fireside chats at:
- Citi’s 17th Annual Biopharma Conference on September 8 at 2:40 pm ET
- Morgan Stanley’s 20th Annual Global Healthcare Conference on September 12 at 2:15 pm ET
Webcast replays will be accessible on the Investors Section of Alvotech’s website for 90 days.
Alvotech (NASDAQ: ALVO) announced it will release its financial results for Q2 and the first half of 2022 on August 31, 2022, after U.S. market close. Following the release, a business update conference call and webcast will take place on September 1, 2022, at 8:00 am ET. Alvotech specializes in biosimilar medicines, with a pipeline of eight candidates targeting various diseases. The company emphasizes growth through strategic global partnerships across multiple regions, including the U.S., Europe, and Asia.