Ranibizumab biosimilar (Xbrane Biopharma)

REYKJAVIK, Iceland and STOCKHOLM, Sweden I March 20, 2025 I Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the acquisition of Xbrane Biopharma AB’s (“Xbrane”) R&D operations and a biosimilar candidate (the “Acquisition”), further expanding Alvotech’s development capabilities, and establishing a footprint in the Swedish life science sector. The Acquisition includes Xbrane’s R&D operations based in Campus Solna, at the Karolinska Institute outside Stockholm, Sweden, as well as the biosimilar candidate XB003, referencing Cimzia® (certolizumab pegol). Xbrane retains other pre-clinical assets and will focus on the commercialization of this portfolio. Alvotech also announced that it intends to explore the possibility of a listing of Swedish Depository Receipts (SDR), equity share equivalents, on Nasdaq Stockholm, in the future. The acquisition in brief “Alvotech has a best-in-class biosimilars manufacturing site in Iceland, both for drug substance and drug products. At the same time, our strong in-house R&D capabilities have put Alvotech in a leading position among pure play biosimilar companies in terms of the market value of our product pipeline. This acquisition will further expand Alvotech’s development capacity, allowing our commercial network of 19 leading commercial partners worldwide to continue increasing patient access to quality biologics,” said Robert Wessman, founder, Chairman and CEO of Alvotech. “Furthermore, we will establish a strong presence for Alvotech in the Swedish life science sector, which rivals the U.S. in this field. It will allow Alvotech to attract new talent, create opportunities for scientific collaboration, and support our growth. This is yet another milestone for Alvotech in establishing us as a leader in biosimilars development and production globally.” “With this transaction Xbrane is significantly strengthening its financial position and retains over 75% of the competitively adjusted addressable market of the portfolio including Ximluci (Lucentis biosimilar candidate) currently being approved and sold in Europe as well as Xdivane (Opdivo biosimilar candidate), recently partnered with Intas. Xbrane will, with a more lean and flexible organization after the transaction, be better equipped to fully focus on realizing the full value of Ximluci and Xdivane with the ambition to generate meaningful royalties/profit sharing from these programs in the years to come,” said Martin Åmark, CEO of Xbrane. Headquartered in Reykjavik, Iceland, Alvotech’s shares are listed on Nasdaq Iceland and Nasdaq US. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Since 2013, Alvotech has invested about $1.9 billion in a purpose-built biosimilars R&D and manufacturing platform, established commercial partnerships with 19 leading companies in over 90 of the largest global markets and developed one of the most valuable portfolios in the biosimilars industry. Advisors DNB Carnegie is acting as financial advisor to Alvotech in connection with the Acquisition. Cirio and Westerberg are legal advisors to Alvotech in connection with the Acquisition. About Alvotech Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com . None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal , and our website or follow us on social media on LinkedIn , Facebook , Instagram , and YouTube . SOURCE: Alvotech

Pictured: Businessmen shaking hands after closing a deal/iStock, Tippapatt Alvotech and Stada have expanded their alliance to include a clinical-stage biosimilar of Amgen’s blockbuster bone drugs Prolia and Xgeva, the companies announced Tuesday. Prolia and Xgeva have the same active ingredient, denosumab, but are approved in different indications. Amgen provides Prolia as a treatment for osteoporosis, both in postmenopausal women at high risk of fracture and in men who need to increase bone mass. Physicians mainly use Xgeva to prevent fractures and other skeletal events in patients with bone metastases from solid tumors and multiple myeloma. The products are among Amgen’s best-selling drugs, with the company reporting Prolia and Xgeva sales of $4 billion and $2.1 billion, respectively, in 2023. Both products are still growing. Prolia sales grew 8% in the first quarter of 2024, while revenues from Xgeva rose 5%. Alvotech and Stada are preparing to provide patients and physicians with biosimilar alternatives to Prolia and Xgeva. Tuesday, Alvotech said Stada has gained semi-exclusive commercial rights for its proposed biosimilar copy of the Amgen drugs in Europe, including Switzerland and the U.K. Stada has also secured exclusive rights to the biosimilar candidate in some markets in Central Asia and the Middle East. Investigators are comparing Alvotech’s AVT03 biosimilar candidate to denosumab in postmenopausal women with osteoporosis in a Phase III clinical trial. The study is scheduled to finish this year. Alvotech remains responsible for developing and manufacturing AVT03. The patents protecting Prolia and Xgeva in Europe expired in 2022 and Sandoz received approval for the first biosimilar copies in the region in May 2024. Sandoz could launch its denosumab biosimilar in the U.S. in May 2025. Organon, which is partnered with Shanghai Henlius Biotech, has applied for approval of another denosumab biosimilar in the European Union. Stada secured rights to AVT03 as part of a broader set of changes to its partnership with Alvotech. The companies partnered to commercialize seven biosimilars in Europe in 2019, leading to the approval of the Humira (adalimumab) biosimilar Hukyndra in 2021. Stada extended its rights to Hukyndra to include countries in Central Asia in parallel to the AVT03 deal. Alvotech also granted Stada rights to a biosimilar of Stelara (ustekinumab) in parts of Central Asia. Stada already had rights to the product, Uzpruvo, in the E.U., where it received authorization earlier this year. Alvotech and Stada are preparing to launch Uzpruvo in Europe. Stada is returning rights to a proposed biosimilar to the eye disease drug Eylea (aflibercept) to Alvotech. The action follows Stada’s launch of a biosimilar of Lucentis (ranibizumab), a drug that competes with Eylea. Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.