Alvotech (NASDAQ:ALVO) and Bioventure said that the Saudi Food & Drug Authority (SFDA) approved the manufacturing and distribution of AVT02, a biosimilar to AbbVie's (NYSE:ABBV) blockbuster drug Humira (adalimumab).
The drug is indicated for to treat rheumatoid arthritis and several other inflammatory diseases.
The biosimilar will be marketed as Simlandi in Saudi Arabia.
Bioventure — a unit of GlobalOne Healthcare Holding (GHH), the healthcare division of Yas Holding — is the exclusive strategic partner for commercializing Simlandi in the Middle East and North Africa.
"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," said Ashraf Radwan, Division CEO of GHH.
This is the first biosimilar approved under this strategic partnership between the companies.
Under the license agreement for AVT02, Alvotech will handle development and manufacturing, while Bioventure will be responsible for selling the biosimilar.