Alvotech and Bioventure have gained approval from the Egyptian Drug Authority to produce and supply AVT02 (adalimumab), a biosimilar for Humira.

The product treats rheumatoid arthritis and other inflammatory ailments.

AVT02 will be marketed as Adalimumab-EVA in Egypt. 

A monoclonal antibody, AVT02 has also gained approvals in regions and countries, including the European Union, the UK, Saudi Arabia and Australia. 

Alvotech chairman and CEO Robert Wessman stated: “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 (MENA).”

Bioventure serves as the strategic partner of Alvotech for marketing AVT02 and other biosimilar candidates in the MENA regions. 

Alvotech is responsible for the development and production of the product while Bioventure handles the marketing. 

The companies are currently marketing AVT02 under the brand name Simlandi, following approval in January 2023.

Bioventure CEO Ashraf Radwan stated: “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. 

“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.”