Core Insights - Dr. Reddy's Laboratories has secured exclusive commercialization rights for AVT03, a biosimilar candidate to Prolia® and Xgeva®, in the U.S. and semi-exclusive rights in Europe and the UK [1][2] - Alvotech will handle the development and manufacturing of AVT03, while Dr. Reddy's will manage registration and commercialization in the relevant markets [2][3] - The agreement includes an upfront payment to Alvotech, with additional payments tied to regulatory and commercialization milestones, as well as sales-based payments [2] Company Overview - Dr. Reddy's Laboratories is a global pharmaceutical company based in Hyderabad, India, focusing on providing affordable and innovative medicines across various therapeutic areas [7][8] - The company has developed a portfolio of biosimilar products and aims to expand its offerings in highly regulated markets [3][8] - Alvotech is a biotech company dedicated to developing and manufacturing biosimilar medicines, with a current pipeline of eight biosimilar candidates targeting various diseases [12] Product Information - AVT03 is a human monoclonal antibody biosimilar candidate to denosumab, indicated for treating osteoporosis and preventing skeletal-related events in patients with advanced malignancies [4] - Positive top-line results from a pharmacokinetic study of AVT03 compared to Prolia® were announced in January 2024, with ongoing studies to confirm efficacy and safety [4] Strategic Collaboration - The partnership between Dr. Reddy's and Alvotech aims to enhance the availability of cost-effective biologic medications globally, emphasizing the importance of biosimilars in healthcare systems [3][12] - Both companies share a commitment to improving patient access to safe and effective biologics, leveraging their combined resources for better service delivery [3][12]

Dr. Reddy's gets exclusive commercialization rights in the United States (U.S.) as well as semi-exclusive rights in Europe and United Kingdom (UK) Alvotech will be responsible for development and manufacture of the product HYDERABAD, India and REYKJAVIK, Iceland, May 21, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide ("Alvotech"), and Dr. Reddy's Laboratories SA, wholly-owned subsidiary ...

SIMLANDI is the first interchangeable high-concentration, citrate-free biosimilar to Humira® REYKJAVIK, Iceland and PARSIPPANY, N.J., May 21, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Alvotech (NASDAQ:ALVO), today announced the availability of SIMLANDI (adalimumab-ryvk) injection in the U.S., as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult ps ...

SIMLANDI is the first interchangeable high-concentration, citrate-free biosimilar to Humira® REYKJAVIK, ICELAND & PARSIPPANY, NJ  — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Alvotech (NASDAQ: ALVO), today announced the availability of SIMLANDI (adalimumab-ryvk) injection in the U.S., as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosin ...

SIMLANDI is the first interchangeable high-concentration, citrate-free biosimilar to Humira® REYKJAVIK, Iceland and PARSIPPANY, N.J., May 21, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Alvotech (NASDAQ: ALVO), today announced the availability of SIMLANDI (adalimumab-ryvk) injection in the U.S., as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult p ...

REYKJAVIK, Iceland, May 13, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2024, after U.S. markets close on Tuesday, May 21, 2024. Alvotech will also conduct a conference call with analysts to present the first quarter 2024 financial results and recent business highlights on Wednesday May 22, 20 ...

REYKJAVIK, Iceland, May 02, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that members of management would be participating in the upcoming BofA Securities Healthcare Conference 2024, which will be held on May 14-15, 2024 in Las Vegas, NV. Members of Alvotech's management team will be attending the conference and hosting one-on-one meetings with investors. About Alvotec ...

The confirmatory clinical safety and efficacy study for AVT05, biosimilar candidate to Simponi® and Simponi Aria® (golimumab), met its primary endpoint in patients with moderate to severe rheumatoid arthritisAlvotech is the first company to publicly announce positive topline results from a patient study evaluating a biosimilar candidate to Simponi or Simponi Aria REYKJAVIK, Iceland, April 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufa ...

Core Insights - The FDA has approved SELARSDI (ustekinumab-aekn) as a biosimilar to Stelara for treating moderate to severe plaque psoriasis and active psoriatic arthritis in both adults and pediatric patients aged 6 years and older [1][2][10] - SELARSDI is expected to be marketed in the U.S. on or after February 21, 2025, following a settlement agreement with Johnson & Johnson [1][3] - The approval of SELARSDI marks the second biosimilar approved under the strategic partnership between Alvotech and Teva, with Teva responsible for its exclusive commercialization in the U.S. [1][4] Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space [8] - Teva Pharmaceutical Industries Ltd. is a global pharmaceutical leader with a strong portfolio, leveraging generics expertise and innovation [9] Market Context - Sales of the reference product Stelara in the U.S. were nearly $7 billion in 2023, indicating significant market potential for SELARSDI [3] - The biosimilars market is growing globally and in the U.S., with biosimilars being a key component of Teva's Pivot to Growth strategy [2] Development and Approval Process - The FDA approval of SELARSDI was based on a comprehensive clinical development program, including studies that demonstrated equivalent efficacy and safety compared to Stelara [5][6] - The development utilized a purpose-built end-to-end platform for biosimilars, employing the same cell type and continuous perfusion process as the reference product [2][5] Strategic Partnership - The strategic partnership between Alvotech and Teva was established in August 2020 for the exclusive commercialization of multiple biosimilar candidates, with recent expansions to include additional products [4] - This partnership allows Teva to leverage its extensive sales and marketing infrastructure to bring biosimilars to market effectively [4]

Company Overview - Alvotech is a biotech company focused on the development and manufacture of biosimilar medicines for patients worldwide [2] - The company aims to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services [2] - Alvotech's current pipeline includes eight disclosed biosimilar candidates targeting autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer [2] Strategic Partnerships - Alvotech has formed a network of strategic commercial partnerships to enhance its global reach and leverage local expertise [2] - Key commercial partners include Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd, and several others across various regions including the US, Europe, Japan, China, and parts of South America, Africa, and the Middle East [2] - Each partnership covers unique products and territories, allowing Alvotech to expand its market presence [2] Market Update - Alvotech will host an audio call for a market update on April 3, 2024, at 12:15 pm GMT / 08:15 am EDT [1] - The update will be provided by Anil Okay, Chief Commercial Officer, and will be accessible via the company's investor website [1] - The webcast will be archived and available for replay for 90 days after the event [1]