REYKJAVIK, Iceland I December 15, 2021 I Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, received approval for AVT02 (100 mg/mL), the company’s high concentration biosimilar to Humira® (adalimumab), from the European Commission (EC) on Nov. 15. The centralized marketing authorization in the European Union (EU) follows the recommendation of the Committee for Medicinal Products for Human Use’s (CHMP) for approval of AVT02 in September, and includes all EU Member States, as well as countries in the European Economic Area (EEA), Iceland, Liechtenstein and Norway.

AVT02 is a high concentration biosimilar to adalimumab (Humira®), which is used to treat a range of certain inflammatory conditions. Adalimumab inhibits tumor necrosis factor, which is a protein in the body that can cause inflammation. Humira® (adalimumab) recorded global sales of about US$20 billion in 2020, making it the highest grossing medicine in the world.

“We are thrilled by the EC’s approval of our high concentration biosimilar to Humira®,” said Róbert Wessman, Founder and Chairman of Alvotech. “As a company, we develop our products with global markets in mind, and we are delighted to receive our first regulatory approval for AVT02”.

Mark Levick, CEO of Alvotech, added, “Alvotech is dedicated to making patients’ lives better by improving access to affordable biosimilar medicines. This news is another milestone in that journey.”

On Dec. 7, 2021, Alvotech and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P. (“Oaktree”), announced they had entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on NASDAQ under the symbol “ALVO.”

About Alvotech

Alvotech is a biopharmaceutical company 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 contains seven biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, and cancer.

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About AVT02

AVT02 is a monoclonal antibody and a biosimilar to Humira (adalimumab). AVT02 is not approved outside of the EU. AVT02 dossiers are under review in multiple countries; in the US the BLA is in deferred status, pending FDA inspections. STADA Arzneimittel AG has exclusive commercialization rights to AVT02 in all key European markets under trade names HUKYNDRA and LIBMYRIS.

SOURCE: Alvotech