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 (NASDAQ: ALVO) is a biotechnology company dedicated exclusively to biosimilars, and its news flow reflects the progress of a global biosimilar platform. Company updates frequently cover regulatory milestones, such as marketing authorizations in the European Economic Area, the United Kingdom and Japan for products referencing Prolia and Xgeva (denosumab), Simponi (golimumab) and Eylea (aflibercept). Press releases also highlight clinical and regulatory developments for new candidates, including submissions to agencies like the European Medicines Agency and the U.S. Food and Drug Administration.
Investors following ALVO news can expect regular announcements on product approvals, pipeline progress and legal or regulatory outcomes. Recent communications have described European Commission approval of AVT03, a biosimilar to Prolia and Xgeva, positive opinions from EMA committees for AVT03 and AVT05, and a settlement and license agreement enabling a future U.S. launch of AVT06, a proposed biosimilar to Eylea, subject to FDA approval. Other items include court decisions related to manufacturing activities for AVT06 and updates on applications for additional candidates such as AVT23.
Alvotech’s news flow also includes capital markets and financing transactions, such as senior unsecured convertible bond offerings and a senior term loan facility, which the company states are intended to support its research and development pipeline, manufacturing capacity and global product launches. Earnings-related press releases and business updates provide guidance ranges for revenues and adjusted EBITDA, along with commentary on order books, launch timing and investment programs.
Corporate governance and leadership changes are another recurring theme. For example, Alvotech has announced a planned CEO succession in which the founder will remain as Executive Chairman while a new Chief Executive Officer takes over day-to-day leadership. For users tracking ALVO, this news page offers a centralized view of regulatory, financial and strategic developments affecting the company’s biosimilar portfolio and global partnerships.
Alvotech (NASDAQ: ALVO) said the European Medicines Agency CHMP issued a positive opinion recommending approval of AVT03, its proposed biosimilar to Prolia® (denosumab 60 mg/mL pre-filled syringe) and Xgeva® (denosumab 70 mg/mL vial), on September 22, 2024. The company said AVT03 remains under EMA review with a final European Commission decision pending. Upon approval, commercial partners STADA and Dr. Reddy’s will market the product in Europe under semi-exclusive rights with assigned tradenames Kefdensis, Zvogra, Acvybra and Xbonzy.
This step affects access to denosumab therapies indicated for osteoporosis, fracture risk and oncology bone complications and moves AVT03 closer to potential European commercialization pending the final regulatory decision.
Alvotech (NASDAQ: ALVO) will release financial results for the six months ended June 30, 2025, after U.S. markets close on Wednesday, August 13, 2025.
The company will host a conference call to present results and business highlights on Thursday, August 14, 2025 at 8:00 am EDT (12:00 noon GMT, 14:00 CET). Live audio will be webcast on Alvotech's investor portal and the webcast will be archived for replay for 90 days. Access details and phone sign-in instructions are posted at https://investors.alvotech.com/events/event-details/q2-2025-earnings.
Alvotech (NASDAQ: ALVO) won expedited UK High Court proceedings brought by Regeneron and Bayer, which rejected requests for an injunction blocking manufacturing at Alvotech’s UK CMO for its biosimilar AVT06 (aflibercept), a biosimilar to Eylea.
The decision permits Alvotech to continue manufacture and storage of AVT06 in the UK for distribution in the UK, EEA and other countries and supports commercial launches after the expiry of Eylea Supplementary Protection Certificates on November 23, 2025. AVT06 received European Commission approval on August 21, 2025 and MHRA approval on August 28, 2025.
Alvotech (NASDAQ: ALVO) and Advanz Pharma announced on November 6, 2025 that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisations for all four presentations of Gobivaz, a biosimilar to Simponi (golimumab).
The authorisations cover 50 mg/0.5 mL and 100 mg/mL formats in both pre-filled syringe and autoinjector forms for rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis (adults), and juvenile idiopathic arthritis across the United Kingdom. The EMA CHMP has issued a positive opinion recommending approval across the European Economic Area.
Under the partnership, Alvotech is responsible for development and commercial supply, while Advanz Pharma holds registration and exclusive commercialisation rights in Europe and the UK.
Alvotech (NASDAQ: ALVO) will release financial results for the first nine months ended September 30, 2025 after U.S. markets close on November 12, 2025. Management will host a conference call and webcast on November 13, 2025 at 8:00 AM EST (13:00 GMT, 14:00 CET) to present results and provide a business update, including the status of pending approvals in the U.S. and Europe.
Live audio and a Q&A participation line will be available, and an audio recording will be archived on the company investor portal for 90 days. Access details and the webcast link are posted at https://investors.alvotech.com/events/event-details/q3-2025-earnings.
Alvotech (NASDAQ: ALVO) will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference in New York from September 8–10, 2025. The company will meet investors on September 9, 2025, and Dr. Balaji Prasad, Chief Strategy Officer, will take part in a fireside chat on September 10, 2025 at 10:45 am EDT (14:45 GMT / 16:45 CET). A live webcast of the fireside chat will be publicly available at the company investor events page.
A recording of the session will be available for replay for 90 days after the event.
Alvotech (NASDAQ: ALVO) said the FDA issued a complete response letter (CRL) for its Biologics License Application for AVT05 (prefilled syringe and autoinjector), citing deficiencies from the FDA pre-license inspection of Alvotech’s Reykjavik facility completed in July 2025 that must be resolved before approval. The FDA identified no other application deficiencies and the facility remains FDA approved to manufacture and continues supplying commercial products. Sales of Simponi in the U.S. were less than $300 million in H1 2025 (IQVIA); no biosimilar to Simponi is currently approved in the U.S.
Alvotech lowered its 2025 outlook to $570–$600M revenue and $130–$150M adjusted EBITDA, citing investments and a temporary production slowdown to address the facility issues.
Alvotech (NASDAQ: ALVO) announced leadership changes in its global business development and commercial operations on October 21, 2025. Anil Okay, Chief Commercial Officer, is stepping down to become CEO of Adalvo. Trisha Durant joins as Senior Vice President, Global Business Development and Commercial Operation, ex-North America; Harshika Sarbajna is Senior Vice President Commercial, North America; and Agne Pasko becomes Vice President Head of Business Development.
The hires combine internal continuity and external experience across North America, Europe and global business development to support Alvotech’s commercial expansion.
Kashiv Biosciences (NASDAQ:ALVO) submitted a BLA to the U.S. FDA and had its MAA accepted by the EMA for ADL-018, a proposed biosimilar to XOLAIR® (omalizumab).
The company highlights ADL-018’s potential to be among the first-wave omalizumab biosimilars addressing a large market: ~$5.5B global, ~$4.1B U.S., and ~$1.0B E.U. annual sales (IQVIA, 12 months ending June 2025). Kashiv partners with Alvotech (AVT23) and cites Amneal’s commercial expectations for multiple biosimilar launches from 2026–2027.
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.