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.
Company Overview
Alvotech is a global biotech company that focuses solely on developing and manufacturing high-quality biosimilar medicines. Utilizing an integrated, end-to-end platform that encompasses every phase from cell line development to commercial manufacturing, Alvotech is committed to transforming access to life-altering therapies for patients worldwide. The company’s approach is built on a foundation of in-depth research and rigorous quality controls that ensure cost-effectiveness and timely production. Key industry terms such as biosimilars, integrated manufacturing, and R&D expertise underscore its standing in the competitive biotechnology space.
Integrated Production and Innovation
At the core of Alvotech's operations is a fully integrated production model that not only strengthens its portfolio of biosimilar medicines but also ensures superior control over quality and cost. With in-house capabilities spanning the entire value chain—from cell culture methodologies to scalable commercial manufacturing—the company delivers robust, evidence-based solutions that address unmet medical needs. This approach supports their ability to rapidly develop biosimilar candidates for therapeutic areas including autoimmune disorders, oncology, and various chronic diseases.
Strategic Collaborations and Global Reach
Alvotech leverages strategic commercial partnerships across key global markets such as North America, Europe, Asia, and emerging regions. These collaborations enrich its market presence and extend its distribution networks, ensuring that biosimilar treatments are accessible in diverse healthcare settings. The company’s alliances with established industry players widen its impact and enhance its expertise, making it a trusted name among healthcare professionals and regulators alike.
Commitment to Quality and Patient Access
Quality is a hallmark of Alvotech’s operations. Every step in the product development process is stringently controlled to meet international regulatory standards. This dedication to quality translates into biosimilar medicines that are both safe and effective, ultimately improving patient outcomes. Alvotech’s mission is to offer therapeutic alternatives that maintain clinical efficacy while reducing treatment costs, thereby delivering significant benefits to patients and healthcare systems globally.
Research & Development and Market Position
Driven by a spirit of innovation, Alvotech continuously invests in its R&D capabilities to stay at the forefront of biosimilar development. Maintaining a diversified pipeline, the company is focused on conditions such as autoimmune disorders, eye diseases, osteoporosis, and respiratory ailments. Its comprehensive expertise in both research and manufacturing positions it uniquely within the biotech industry, allowing for a faster response to clinical challenges and regulatory demands while emphasizing a commitment to evidence-based therapeutic solutions.
Conclusion
In summary, Alvotech exemplifies a modern, fully integrated biotech enterprise with a dedicated focus on biosimilar medicines. Its strategic blend of in-house R&D, manufacturing agility, and global partnerships creates a robust platform that enhances patient access to critical therapies. For investors and industry stakeholders, the company represents a synthesis of specialized expertise, operational excellence, and a clear mission to improve healthcare outcomes worldwide.
Teva Pharmaceuticals and Alvotech have announced the U.S. launch of SELARSDI™, their second biosimilar under their strategic partnership. SELARSDI, a biosimilar to Stelara® (ustekinumab), received FDA approval in October 2024 for treating multiple conditions including psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis in both adults and children.
The FDA has provisionally determined SELARSDI's interchangeability with Stelara® following April 30, 2025. The drug is available in four presentations matching Stelara's approved formats. This launch follows their first biosimilar SIMLANDI®, approved in February 2024 and launched in May 2024.
Under the partnership, Alvotech handles development and manufacturing, while Teva manages U.S. commercialization. Their collaboration, initiated in August 2020, now covers seven biosimilar products.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has appointed Dr. Balaji V. Prasad as Chief Strategy Officer. Dr. Prasad brings 25 years of pharmaceutical industry experience, combining medical expertise with financial analysis background.
Most recently serving as a director and equities analyst at Barclays, Dr. Prasad covered US specialty pharma with Alvotech in his portfolio. His previous roles include portfolio manager at a Swiss asset management firm and leadership positions at Barclays and Goldman Sachs India healthcare coverage. He holds an MD from Bangalore Medical College and MBA from IIM Ahmedabad.
Alvotech (NASDAQ: ALVO) reported exceptional financial results for 2024, with total revenues reaching $492 million, a 427% increase year-over-year. Product revenues surged 462% to $273 million, while the company achieved positive Adjusted EBITDA of $108.3 million, compared to negative $291 million in 2023.
Key highlights include the successful submission and acceptance of three new proposed biosimilars in major global markets, the launch of SELARSDI™ (ustekinumab-aekn) in the U.S., and the acquisition of XBrane's R&D operations. The company reported an operating profit of $69.6 million, marking a significant improvement from the previous year's loss of $354.9 million.
Despite strong operational performance, Alvotech recorded a net loss of $231.9 million ($0.87 per share) for 2024, primarily due to finance costs and debt refinancing impacts. The company ended the year with $51.4 million in cash and cash equivalents.
Alvotech (NASDAQ: ALVO), along with Kashiv Biosciences and Advanz Pharma, announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted their marketing application for AVT23, a proposed biosimilar to Xolair® (omalizumab).
The biosimilar is intended for treating severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps. The original drug, Xolair, generated global sales of approximately $4.4 billion in 2024.
This development follows strategic partnerships formed in 2023, including a commercialization agreement between Alvotech and Advanz Pharma for AVT23 in February, an expanded partnership in May covering five additional biosimilar candidates, and a licensing agreement between Alvotech and Kashiv in October.
Alvotech (NASDAQ: ALVO) has announced the acquisition of Xbrane Biopharma AB's R&D operations and biosimilar candidate XB003 for approximately SEK 275 million (USD 27 million). The deal includes Xbrane's R&D facilities at Campus Solna, Karolinska Institute, Stockholm, establishing Alvotech's presence in the Swedish life science sector.
The purchase will be completed through SEK 102.2 million in cash and SEK 172.8 million in debt assumption, with creditors agreeing to accept SEK 152.8 million in Alvotech equity shares. The acquisition is expected to close in April 2025, pending regulatory and shareholder approvals.
This strategic move expands Alvotech's development capabilities and strengthens its position in the biosimilars market. The company currently operates with 19 commercial partners worldwide and has invested approximately $1.9 billion in its biosimilars platform since 2013. Xbrane will retain some pre-clinical development programs and continue as a listed company, maintaining over 75% of its portfolio's addressable market.
The FDA has accepted a Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab), jointly announced by Dr. Reddy's Laboratories and Alvotech. AVT03 aims to treat osteoporosis in post-menopausal women and prevent bone complications in cancer patients.
Under a License and Supply Agreement from May 2024, Alvotech will handle development and manufacturing, while Dr. Reddy's will manage registration and commercialization in applicable markets, including the U.S. Upon FDA approval, AVT03 will be available in two formulations: a 60 mg/1 mL single-dose prefilled syringe and a 120 mg/1.7 mL single-dose vial.
Alvotech (NASDAQ: ALVO) and Dr. Reddy's announced that the FDA has accepted their 351(k) Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab). The biosimilar aims to treat osteoporosis in post-menopausal women and prevent bone complications in cancer patients.
Under their License and Supply Agreement from May 2024, Alvotech will handle development and manufacturing, while Dr. Reddy's will manage registration and commercialization in key markets, including the U.S. Upon FDA approval, AVT03 will be available in two formulations: a 60 mg/1 mL single-dose prefilled syringe and a 120 mg/1.7 mL single-dose vial.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has announced its participation in the Barclays 27th Annual Global Healthcare Conference in Miami, Florida from March 11-13, 2025.
The company's founder, chairman and CEO Robert Wessman, along with management team members, will conduct one-on-one meetings during the event. Additionally, Alvotech will participate in a fireside chat on March 12, 2025, from 9:30-9:55 am EDT. The session will be available via audio webcast in the Events Section of Alvotech's Investor Portal, with the recording accessible for 90 days post-event.
Alvotech and Teva Pharmaceuticals announced that the FDA has accepted for review Biologics License Applications (BLA) for AVT05, their proposed biosimilar to Simponi® and Simponi Aria® (golimumab). This marks the first U.S. BLA acceptance for a golimumab biosimilar candidate, with FDA review expected to complete in Q4 2025.
The announcement follows positive top-line results from clinical studies in April 2024 for rheumatoid arthritis patients and pharmacokinetic studies in November 2023. This development is part of a strategic partnership between Alvotech and Teva, which now encompasses nine biosimilar products.
The partnership has already achieved FDA approval for two other biosimilars: SIMLANDI® (adalimumab-ryvk) in February 2024 and SELARSDITM (ustekinumab-aekn) in April 2024. SIMLANDI launched in May 2024, while SELARSDITM is planned for U.S. market entry in February 2025.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has scheduled its full year 2024 financial results announcement for March 26, 2025, after U.S. markets close. The company will host an analyst conference call on March 27, 2025, at 8:00 am ET (12 noon GMT).
A live audio webcast of the conference call will be available to investors, media, and the public. The webcast recording will remain accessible for 90 days after the event on Alvotech's investor website. Additionally, the company will host a local investor event in Icelandic at Sæmundargata 15-19, Reykjavik, on March 27, 2025, at 4:00 pm GMT.
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