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 global biopharmaceutical company dedicated to improving patient access to affordable biologic medicines through the development, manufacturing, and commercialization of high-quality biosimilars. Founded in 2013, Alvotech operates as a fully integrated organization, controlling every step of the biosimilar value chain, from cell line development to large-scale commercial production. Headquartered in Reykjavik, Iceland, the company leverages its state-of-the-art manufacturing facilities and R&D capabilities across Europe to ensure cost-effective and timely delivery of its products.
Alvotech’s core mission is to transform access to life-altering therapies by addressing the rising costs of biologic treatments. The company specializes in biosimilars, which are highly similar, clinically equivalent, and more cost-effective alternatives to branded biologic drugs. Its portfolio spans multiple therapeutic areas, including autoimmune disorders, oncology, respiratory diseases, osteoporosis, and ophthalmology. Two of its biosimilars, targeting Humira® (adalimumab) and Stelara® (ustekinumab), have already been approved and launched in key global markets, with several others in advanced stages of development.
End-to-End Capabilities and Competitive Advantage
Alvotech’s vertically integrated approach is a cornerstone of its business model, enabling it to maintain complete control over the biosimilar development process. This includes proprietary cell line development, clinical trials, regulatory submissions, and commercial manufacturing. Its flexible manufacturing platform in Reykjavik is designed to accommodate the production of multiple biosimilar candidates simultaneously, ensuring scalability and cost efficiency. This operational model not only reduces time-to-market but also ensures consistent product quality, a critical factor in gaining regulatory and market acceptance.
Global Partnerships and Market Reach
To maximize its global footprint, Alvotech has established a robust network of strategic partnerships with leading pharmaceutical companies, including Teva Pharmaceuticals, Stada Arzneimittel AG, and Advanz Pharma. These collaborations allow Alvotech to leverage local expertise and distribution networks in regions such as North America, Europe, Asia, and South America. This strategy has enabled the company to navigate complex regulatory landscapes and accelerate the commercialization of its biosimilars in diverse markets.
Pipeline and Future Growth
Alvotech’s development pipeline includes nine disclosed biosimilar candidates targeting high-demand biologics such as Eylea® (aflibercept), Prolia®/Xgeva® (denosumab), and Simponi® (golimumab). These candidates address critical therapeutic areas, including autoimmune diseases, retinal disorders, and bone-related conditions. The company’s ongoing clinical trials and regulatory filings demonstrate its commitment to expanding its portfolio and delivering innovative, cost-effective solutions to patients worldwide.
Industry Challenges and Differentiation
Operating in the highly competitive biosimilars market, Alvotech faces challenges such as stringent regulatory requirements, the complexities of biologic manufacturing, and competition from both branded biologics and other biosimilar manufacturers. However, its integrated platform, focus on high-value therapeutic areas, and strategic partnerships position it as a strong contender in the global biosimilars landscape.
Through its unwavering commitment to quality, innovation, and accessibility, Alvotech continues to play a pivotal role in addressing the global healthcare challenge of rising biologic drug costs, making life-altering therapies more accessible to patients worldwide.
Alvotech (NASDAQ: ALVO) and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, a proposed biosimilar to Simponi® (golimumab). This marks the first globally announced marketing authorization application for a Simponi biosimilar candidate. The approval process is expected to complete in Q4 2025.
The companies expanded their partnership in May to include AVT05 and other biosimilar candidates. Positive results from both a confirmatory clinical study in rheumatoid arthritis patients and a pharmacokinetic study in healthy participants were previously announced in April 2024 and November 2023, respectively.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, has scheduled its financial results release for the first nine months of 2024. The results will be announced after U.S. markets close on November 13, 2024, followed by an analyst conference call on November 14, 2024, at 8:00 am ET. The conference call will be accessible via webcast through Alvotech's investor portal, with replay available for 90 days after the event.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines development, announced its participation in the Jefferies London Healthcare Conference on November 19-20, 2024. The company's management will conduct one-on-one meetings during both days and deliver a presentation on November 19 at 9:00 AM GMT. An audio webcast will be available in the Investors Section of Alvotech's website, with the recording accessible for 90 days post-event.
Alvotech and Teva announce FDA approval of SELARSDI™ (ustekinumab-aekn) 130 mg/26 mL in a single-dose vial for intravenous infusion. This expands the label to include treatment of adults with Crohn's disease and ulcerative colitis. The FDA previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection in April 2024.
SELARSDI's U.S. launch for all indications is expected in Q1 2025. This approval aligns SELARSDI's label with the indications of the reference product Stelara® (ustekinumab). Alvotech developed SELARSDI using Sp2/0 cells and a continuous perfusion process, similar to the reference product. Ustekinumab targets the p40 protein, important in treating immune-mediated diseases.
Alvotech and Teva's partnership now includes nine products, with Alvotech handling development and manufacturing, and Teva responsible for U.S. commercialization.
Alvotech (NASDAQ: ALVO) announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab). This marks a significant step towards making AVT03 available in Europe. Alvotech develops and manufactures AVT03, while STADA Arzneimittel AG and Dr. Reddy's Laboratories SA have agreements for its commercialization in Europe.
In July 2024, Alvotech reported positive topline results from confirmatory studies demonstrating clinical similarity of AVT03 to Prolia and Xgeva. The European denosumab market is currently valued at approximately US$1 billion. Biosimilar competition could expand patient access at the same or lower costs, addressing the significant burden of osteoporosis in Europe, where an estimated 32 million individuals are affected.
Alvotech (NASDAQ: ALVO) announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab). This marks a significant step towards making AVT03 available in Europe.
The company recently reported positive topline results from confirmatory studies for AVT03, demonstrating clinical similarity to Prolia in efficacy, safety, immunogenicity, and pharmacokinetics. Alvotech develops and manufactures AVT03, with STADA Arzneimittel AG and Dr. Reddy's Laboratories SA as commercial partners in Europe.
The European denosumab market is valued at approximately US$1 billion. Biosimilar competition could expand patient access at lower costs, addressing the significant burden of osteoporosis in Europe, where an estimated 32 million individuals are affected, but 70% of eligible women do not receive treatment.
Alvotech (NASDAQ: ALVO) has initiated a confirmatory patient study for AVT16, a proposed biosimilar to Entyvio® (vedolizumab). The study aims to demonstrate comparative efficacy, safety, and immunogenicity in participants aged 18-80 with moderate to severe active Ulcerative Colitis. Alvotech is one of only two companies known to have started such a study for an Entyvio biosimilar.
Entyvio, with global sales of about $5.4 billion in the last 12 months until June 30, 2024, is used to treat Ulcerative Colitis and Crohn's disease. The AVT16-GL-C01 study has a double-blind parallel design with two arms, comparing AVT16 to Entyvio.
Alvotech's growing pipeline includes biosimilars targeting autoimmune disease, eye disorders, bone disease, respiratory disease, and cancer. The company expects to file marketing applications for three biosimilar candidates in 2024, with AVT16 being one of six disclosed biosimilar programs in earlier development stages.
AECOM (NYSE: ACM) has been selected by the City of Austin as the prime consultant for the expansion of the Walnut Creek Wastewater Treatment Plant (WWTP) in Austin, Texas. The project aims to increase the plant's capacity from 75 million gallons per day (MGD) to 100 MGD, addressing the needs of Austin's growing population and enhancing the resilience of its wastewater infrastructure.
The scope of work includes process, mechanical, civil, electrical, and structural engineering services to modernize and upgrade existing infrastructure. Key components of the expansion include:
- Replacing aging equipment
- Constructing a new 25 MGD treatment train
- Building a new 120-inch outfall line and structure
- Providing wet weather treatment with new 100 MGD cloth filters
- Building a flood wall for protection against 100-year floods
The Walnut Creek WWTP, originally built in 1977, has undergone three previous expansions. The facility is expected to remain operational throughout the upgrade process.
Alvotech (NASDAQ: ALVO), a global biotech company focused on biosimilar medicines, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference in New York. The company's management team will engage in an in-person fireside chat on September 5, 2024, at 5:35 pm EDT (21:35 GMT).
Investors and interested parties can access a live audio webcast of the fireside chat through Alvotech's investor website in the events section. For those unable to attend live, a recording will be archived and available for at least 90 days after the event, providing an opportunity to gain insights into Alvotech's strategies and developments in the biosimilar market.
Alvotech (NASDAQ: ALVO) reported record financial results for Q2 and H1 2024, with total revenues reaching $236 million in H1, a ten-fold increase year-over-year. Product revenues grew 190% to $66 million, while license and other revenues surged to $170 million. The company achieved positive Adjusted EBITDA of $64 million in H1, compared to a loss of $147 million in the same period last year.
Key highlights include:
- U.S. order book for biosimilar Humira increased to 1.3 million units for 2024
- Successful launches of biosimilars in multiple markets
- Positive clinical results for AVT03, a proposed biosimilar to Prolia® and Xgeva®
- Expanded partnerships with STADA and Advanz Pharma
- Refinancing of debt obligations, improving overall debt profile
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