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.
Alvotech (NASDAQ: ALVO) announces that its biosimilar AVT02, a high-concentration, low-volume formulation of adalimumab, has received marketing authorization from the Therapeutic Goods Administration in Australia. Marketed under the names Ciptunec™ and Ardalicip™, this biosimilar is now available for various indications, including rheumatoid arthritis and Crohn's disease. This is the first biosimilar resulting from Alvotech's partnership with Cipla, aiming to enhance access to affordable biologics in Australia and other regions.
Alvotech (NASDAQ: ALVO) announced its participation in the American College of Rheumatology (ACR) Convergence Conference, where it will present two posters and host an Ignite Talk on its switching study for ATV02.
The study focuses on the pharmacokinetics, immunogenicity, efficacy, and safety of switching between Humira and AVT02, a high-concentration biosimilar candidate. The FDA accepted Alvotech’s Biologics License Application for interchangeability in February 2022, currently under review. This work emphasizes improving patient access to biologics while reducing costs.
Alvotech (NASDAQ: ALVO), a biotech company focused on biosimilars, is set to release its financial results for the first nine months of 2022 on November 15, 2022, after U.S. market close. A business update conference call will follow on November 16, 2022, at 8:00 am ET. Alvotech aims to be a leader in biosimilar medicines, with eight candidates in its pipeline targeting diseases such as autoimmune disorders and cancer. The company is partnered with numerous commercial entities globally to enhance market reach.
Alvotech (NASDAQ: ALVO), a biotech company focused on biosimilar medicines, will participate in the Jefferies London Healthcare Conference from November 15 to November 17, 2022. The leadership team plans to present on November 17 at 10:25 am GMT and will conduct investor meetings throughout the event.
A webcast of the presentation will be accessible on Alvotech’s website for 90 days post-conference.
Alvotech (NASDAQ: ALVO) has announced an expanded partnership with JAMP Pharma Group to commercialize two new biosimilar candidates, AVT16 and AVT33, in Canada. This partnership builds on their previous success with Simlandi™, a biosimilar to Humira, launched in April 2022. Alvotech will develop and supply these biosimilars, while JAMP Pharma will manage marketing and sales in Canada, aiming to enhance patient access to affordable biologics. The partnership aligns with Alvotech's goal to lead in the Canadian biosimilars market.
Alvotech (NASDAQ: ALVO), a biotech firm, has announced that its partner, Fuji Pharma Co., Ltd., has submitted a marketing approval application to Japan's Ministry of Health for their first biosimilar candidate. This marks a significant milestone in their exclusive partnership aimed at increasing access to essential biologics in Japan. Alvotech's pipeline includes eight biosimilar candidates targeting various diseases, positioning them to meet the rising demand for biosimilars in Japan and beyond.
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.