Alvotech and Bioventure Announce Approval of AVT02 (adalimumab) as Simlandi in Saudi Arabia
REYKJAVIK, Iceland and DUBAI, United Arab Emirates, Jan. 24, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) and Bioventure, a wholly owned subsidiary of GlobalOne Healthcare Holding LLC (“GHH”), the healthcare division of Yas Holding LLC, today announced that the Saudi Food & Drug Authority (“SFDA”) has approved the manufacturing and distribution of AVT02, a biosimilar for Humira® (adalimumab), which is commonly indicated for the treatment of rheumatoid arthritis and several other inflammatory diseases. The biosimilar will be marketed as Simlandi™ in Saudi Arabia.
A biosimilar is a biologic medicine that is highly similar to and has no clinically meaningful differences from an existing approved biologic medicine but can be more affordable than the reference product. In the last twelve months reported, ending on October 1, 2022, Humira (adalimumab) was the world’s highest-grossing pharmaceutical product, other than COVID-19 vaccines, with global sales of US$21 billion, according to the manufacturer of the reference product .
“The approval of Simlandi by the SFDA marks an important milestone for local patients and physicians,” said Ashraf Radwan, Division CEO of GlobalOne Healthcare Holding. “We are proud to partner with Alvotech, who share our mission to lower the cost burden on healthcare systems and improve patient quality of life. We look forward to bringing this essential treatment to patients in Saudi Arabia as well as other key markets in the Middle East and North Africa.”
Robert Wessman, Founder, Chairman and CEO of Alvotech, added: “Approval in Saudi Arabia is a significant step in Alvotech’s journey to offer broader access worldwide to more affordable biologics. We believe that biosimilars are important in addressing inflationary pressures for healthcare systems in all markets, especially where the penetration of biologics has been depressed due to high cost and lack of access.”
Bioventure is Alvotech’s exclusive strategic partner for the commercialization of Simlandi in the Middle East and North Africa. Bioventure and Alvotech have previously entered into license agreements for multiple biosimilars.
Under the terms of the license agreement for AVT02 between Alvotech and Bioventure, Alvotech will handle development and manufacturing, while Bioventure will be responsible for the commercialization of the biosimilar. This is the first biosimilar approved under this strategic partnership.
 Source: Quarterly financial reports by AbbVie
About AVT02 / Simlandi™ (adalimumab)
Established as the investment arm of GlobalOne Healthcare Holding LLC, Bioventure aims to support innovation, business development, and global reach of value-added healthcare solutions.
Bioventure’s three-strand approach includes licensing, investment, and increased market access. It helps pharmaceutical companies license biosimilars and new innovative products, as well as expand market presence and manufacturing capabilities. The company is the exclusive license holder for Alvotech’s biosimilar portfolio and pipeline within the Middle East and Africa.
Bioventure partners with late-stage biotech as well as health/medtech startups to help drive innovation and excellence within the region. It does so through licensing, registration, acquisition, and strategic investment. For more information, please visit: www.yasholding.ae/bioventure/
About GlobalOne Healthcare
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