Certolizumab Pegol

New Delhi: Indian drugmaker Lupin Limited (Lupin) has entered into a license and supply agreement with Zentiva Group (Zentiva) to market its autoimmune disease biosimilar Certolizumab Pegol in Europe and other CIS markets. Disclosing the purchase price of the agreement, the drugmaker said that upon completion, it will receive an initial payment of $10 million and milestone payments of up to $50 million — bringing the total deal value to $60 million (around ₹510 crore)." As per the company stock exchange filing, both parties will invest in the development of the new biosimilar and the profits from the defined markets will be shared between the two companies. “Zentiva, with its pan European focus, enables Lupin to commercialize this unique biosimilar in its core markets and ensure accessibility and affordability of transformative therapies worldwide,” Fabrice Egros, President, Corporate Development, Lupin, said. Under the agreement, Lupin will handle the development, manufacturing and supply of the product within the agreed territories and Zentiva will oversee commercialization activities in Europe and CIS markets (former Soviet republics). The Indian drugmaker has stated to keep the market rights of major markets like US, Canada where it holds a strong commercial presence. Certolizumab Pegol is a recombinant, humanized antibody indicated for the treatment of autoimmune diseases like arthritis, psoriatic and Crohn’s disease. The drug targets and inhibits a protein called TNF-alpha (tumor necrosis factor alpha) which triggers inflammation and helps to reduce joint pain and muscle damage. By Online Bureau ,

REYKJAVIK, Iceland and LONDON, UK I July 1, 2025 I Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into a supply and commercialization agreement for AVT10, Alvotech’s biosimilar candidate to Cimzia® (certolizumab pegol). “Our biosimilar candidate is the only one referencing Cimzia® that is under development globally and the reference product has carved out significant market share as treatment for chronic rheumatic diseases, especially for women of childbearing age. I’m very pleased to add it to our expanding commercial partnership with Advanz Pharma,” said Róbert Wessman, Chairman and CEO of Alvotech. “This agreement further strengthens our strategic partnership with Alvotech and supports our goal to expand access to high-quality biologics for patients in Europe. A proposed biosimilar to Cimzia® is a valuable addition to our sizable biosimilars pipeline.” said Steffen Wagner, CEO of Advanz Pharma. Certolizumab pegol is a TNF-alpha inhibitor indicated for a variety of inflammatory diseases. Worldwide sales of Cimzia® in 2024 were US$2.3 billion [1]. Alvotech and Advanz Pharma have previously entered into partnership agreements for biosimilar candidates to more than ten reference biologics. The companies expect to launch their first biosimilars in Europe in Q4 2025. Use of trademarks Cimzia® is a registered trademark of UCB Pharma S.A. Sources [1] Global Data 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. Alvotech’s current pipeline includes eight 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), 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 www.alvotech.com . None of the information on the Alvotech website shall be deemed part of this press release. About Advanz Pharma Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, biosimilars & specialty generics, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, rheumatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity. SOURCE: Alvotech