"Alvotech and Teva Pharmaceuticals have confirmed that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Applications (BLA) for AVT05, a proposed biosimilar to Simponi® and Simponi Aria® (golimumab).
AVT05 is a biosimilar candidate to Simponi® and Simponi Aria® (golimumab), a monoclonal antibody that targets tumour necrosis factor alpha (TNF alpha), a protein implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
AVT05 is currently an investigational product and has not yet been approved in any country.
SIMLANDI is a monoclonal antibody approved as a biosimilar to Humira® (adalimumab) in more than 50 countries, including the U.S., Europe, Canada, and Australia.
It is marketed in various regions under different brand names, including SIMLANDI in the U.S., HUKYNDRA® in Europe, and ADALACIP® in Australia.
SELARSDI™ is a monoclonal antibody biosimilar to Stelara® (ustekinumab), which binds to cytokines IL-12 and IL-23 involved in immune responses. SELARSDI™ has been launched in Canada, Europe, and Japan, and is expected to be available in the U.S. in 2025.
The product is also under review in various other countries.
This marks the first BLA filing acceptance for a biosimilar candidate to golimumab in the U.S. The FDA is expected to complete its review of these applications in the fourth quarter of 2025.
AVT05 is designed to treat inflammatory conditions, and Alvotech’s development process has been built to match the manufacturing cell line and process of the reference biologic. This alignment is seen as a critical step in developing the biosimilar for global markets.
In April 2024, Alvotech shared positive results from a clinical study that compared AVT05 to Simponi® in patients with moderate to severe rheumatoid arthritis. The company also previously announced successful pharmacokinetic study results in November 2023.
Alvotech and Teva entered into a strategic partnership in August 2020 to exclusively commercialise five of Alvotech’s biosimilar candidates, including AVT05. Since then, the partnership has expanded to include nine products.
Alvotech manages development and manufacturing, while Teva oversees commercialisation in the U.S.
Two biosimilars developed under this partnership have already received FDA approval.
In February 2024, the FDA approved SIMLANDI® (adalimumab-ryvk), a biosimilar to Humira® (adalimumab), and in April 2024, the FDA approved SELARSDI™ (ustekinumab-aekn), a biosimilar to Stelara® (ustekinumab). SELARSDI™ is expected to be available in the U.S. by February 2025.