Reykjavik, Iceland & Dubai, United Arab Emirates — Alvotech (NASDAQ: ALVO) and Bioventure, a wholly owned subsidiary of GlobalOne Healthcare Holding LLC, today announced that the Egyptian Drug Authority (EDA) has approved the manufacturing and distribution of AVT02 (adalimumab) a biosimilar for Humira®, which is commonly indicated for the treatment of rheumatoid arthritis and several other inflammatory diseases, under the trade name Adalimumab-EVA™.

A biosimilar is a biologic medicine that is highly similar to and has no clinically meaningful differences from an existing approved biologic medicine or reference product. The development and advancement of biologics has provided novel and life-changing treatments across therapeutic areas and for a variety of chronic diseases. The introduction of biosimilars frequently leads to higher utilization of the molecule as lower costs offer increased access to patients [1].

“We are very pleased with the approval of AVT02 in Egypt. Alvotech’s mission is to increase patient access worldwide to more affordable biologics and this represents another important milestone in our partnership covering the Middle East and North Africa,” said Robert Wessman, Chairman and CEO of Alvotech.

“Remaining determined in our commitment to enhance healthcare access and improve patient well-being, today we mark an important milestone as Bioventure and Alvotech celebrate the approval of AVT02 in Egypt,” stated Ashraf Radwan, CEO of Global One Healthcare Holding and Bioventure.
“At Bioventure, we are dedicated to developing products and services that enhance patients’ quality of life, driven by our vision of a world where the benefits of biotechnology are accessible to all.”

Bioventure is Alvotech’s exclusive strategic partner for the commercialization of AVT02 (adalimumab) and other biosimilar candidates in the Middle East and North Africa. Alvotech handles development and manufacturing, while Bioventure is responsible for commercialization. The partnership earlier announced the approval of AVT02 in Saudi Arabia, where it will be marketed as Simlandi™.

[1] IQVIA (2023) “Biosimilars in the United States 2023-2027”