FDA agrees to review application for Simponi biosimilar
Alvotech, Teva expect review process to be completed by year-end
The U.S. Food and Drug Administration (FDA) has agreed to review an application seeking approval of AVT05, a proposed biosimilar for Simponi (golimumab), which is an approved treatment for ankylosing spondylitis.
Developers Alvotech and Teva Pharmaceuticals said this marks the first time that the FDA has agreed to review an application for a biosimilar of Simponi. The companies said they expect a decision from the FDA in the fourth quarter.
Biosimilars are medications designed to work in the same way as reference biological drugs. Biosimilars are basically analogous to generic versions of traditional medications, but since biological drugs like Simponi are made using living cells as part of the manufacturing process, the regulatory requirements and terminology are a bit different. Like generics, biosimilars are usually cheaper than the reference product, and by introducing competition into the pharmaceutical marketplace, they can help drive down costs and expand access.
“Biosimilars are ushering a new treatment paradigm and have become an integral staple in the healthcare ecosystem,” Thomas Rainey, senior vice president of U.S. Biosimilars at Teva, said in a press release from the two companies.
Joseph McClellan, PhD, chief scientific officer of Alvotech, said the FDA’s acceptance of the application is “a significant step towards being able to offer U.S. patients access to biosimilar golimumab.”
Blocking protein to ease inflammation
Simponi is designed to block the activity of an inflammatory signaling protein called tumor necrosis factor-alpha (TNF-alpha). By blocking this protein, the therapy works to dampen inflammation. It is approved to treat active ankylosing spondylitis as well as several other inflammatory diseases, including rheumatoid arthritis and psoriatic arthritis.
Two versions of the drug are approved to treat ankylosing spondylitis: Simponi, which is given monthly via injection under the skin, and Simponi Aria, which is given by infusions into the bloodstream at weeks 0 and 4, and every other month thereafter. Both versions use the same active ingredient, golimumab, and AVT05 aims to provide a biosimilar for both.
“Our in-house capability allowing us to match the cell line and process used to manufacture the reference biologic, has given us an important head start in developing a biosimilar candidate to Simponi and Simponi Aria for global markets,” McClellan said.
A Phase 1 clinical trial (NCT05632211) compared AVT05 against Simponi in healthy volunteers, showing that the two drugs had comparable pharmacological and safety profiles. Alvotech has also conducted a Phase 3 trial called ALVOFLEX (NCT05842213) that compared AVT05 and Simponi in people with rheumatoid arthritis, with results showing the two were similarly effective at controlling inflammation.
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