•  Upon launch, HUKYNDRA® will be one of two citrate-free, high-concentration adalimumab biosimilars on the European market
  • All intellectual-property disputes related to market entry of Alvotech’s AVT02 (adalimumab) in the U.S. and Europe are now resolved

REYKJAVIK, Iceland & BAD VILBEL, Germany I April 06, 2022 I Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, has today announced the resolution of all intellectual property disputes with AbbVie in Europe and selected markets outside of Europe, related to its AVT02 biosimilar candidate. This paves the way for Alvotech’s exclusive strategic partner STADA to commercialize AVT02, a citrate-free, high-concentration (100 mg/mL) biosimilar to Humira® (adalimumab) in European countries under the HUKYNDRA® brand name.

Under the terms of the European patent resolution, AbbVie has granted Alvotech a non-exclusive, royalty bearing license to AbbVie’s intellectual property relating to Humira® in Europe and in selected markets outside of Europe, thus paving the way for greater patient access to adalimumab.

“This resolution is an important step in Alvotech’s mission to bring more sustainable healthcare to patients in need and we look forward to launching our first biosimilar in the European market with STADA,” said Robert Wessman, Founder and Chairman of Alvotech.

With all intellectual-property issues now resolved, STADA is preparing to launch the HUKYNDRA citrate-free, high-concentration biosimilar broadly across Europe. STADA is Alvotech’s exclusive strategic partner for commercializing AVT02 in Europe and selected other territories.

“HUKYNDRA will be the first of what we anticipate will be a continuous stream of biosimilar launches across a broad range of therapeutic categories through our partnership with Alvotech.,” said Peter Goldschmidt, CEO of STADA. “We are committed to working with partners to bring competition to the biologic medicines sector, thereby delivering value and facilitating patient access.”

HUKYNDRA is the first of seven molecules covered by an exclusive biosimilars agreement signed between Alvotech and STADA in November 2019. This broad partnership includes biosimilar candidates aimed at treating autoimmunity, oncology, and ophthalmology conditions.

In December 2021, the partners announced that they had received approval from the European Commission for AVT02 (adalimumab), now called HUKYNDRA in Europe, the company’s citrate-free, 100 mg/mL high concentration biosimilar to Humira®, for the 27 member countries of the European Union plus Norway, Iceland and Liechtenstein.

HUKYNDRA is authorized for use in treating a range of inflammatory conditions including rheumatoid arthritis, plaque psoriasis and Crohn’s disease. Adalimumab inhibits tumor necrosis factor alpha, which is a protein in the body involved in inflammation. Humira® was the highest grossing medicine in the world in 2021 (excluding COVID-19 vaccines) with global sales of over $20 billion.

In February 2022, the US Food and Drug Administration (FDA) accepted for review a Biologics License 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).

SOURCE: Alvotech