In February 2022, the US Food and Drug Administration (FDA) accepted for review a Biologics Licensing Application (BLA) for ATV02 (100 mg/mL), Alvotech’s citrate-free, high-concentration biosimilar, that includes new data supporting interchangeability between ATV02 and Humira®, for the U.S. market. The application was supported by positive results from a switching study that demonstrates bioequivalence and comparable efficacy, safety and immunogenicity of repeated switches between administration of Humira® and AVT02.
On December 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., 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, 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 contains eight biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, asthma and cancer. For more information, please visit www.alvotech.com.
About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of generics, specialty pharma and consumer healthcare products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2021, STADA achieved group sales of EUR 3,249.5 million and reported earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 776.5 million. As of 31 December 2021, STADA employed 12,520 people worldwide.
About AVT02
AVT02 is a monoclonal antibody and a biosimilar to Humira® (adalimumab). AVT02 is not approved outside of the EU (Hukyndra®), Canada (Simlandi™), and the United Kingdom (Hukyndra®). AVT02 dossiers are under review in multiple countries; in the U.S. the BLA is in deferred status, pending FDA inspection(s).
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STADA Executive Board: Peter Goldschmidt (CEO) / Dr. Wolfgang Ollig / Simone Berger / Miguel Pagan Fernandez Supervisory Board Chairman: Dr. Günter von Au |
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04/06/2021 | | Caring for People’s Health | | Page 3 of 7 |