Alvotech (ALVO), a biotech company, and Teva Pharmaceutical Industries Limited (TEVA), a pharmaceutical company, on Monday, announced that the FDA has accepted for review the Biologics License Application for AVT05.
AVT05 is a biosimilar candidate to Johnson & Johnson's (JNJ) Simponi and Simponi Aria, also known by their generic name, golimumab, which are approved to treat a variety of inflammatory conditions.
This marks the first U.S. BLA filing for a biosimilar to Simponi/Simponi Aria, with the FDA review expected to be completed by the fourth quarter of 2025.
The combined global sales of Simponi/Simponi Aria for the nine months ended Sep.30, 2024, were $1.61 billion compared to $1.69 billion in the year-ago period.
Joseph McClellan, Chief Scientific Officer of Alvotech, said, "This is a significant step towards offering U.S. patients access to biosimilar golimumab. Our ability to match the reference biologic's manufacturing process gives us a head start in developing this biosimilar for global markets."
Thomas Rainey, Senior VP of U.S. Biosimilars at Teva, added, "Teva's partnership with Alvotech reflects our commitment to bringing cost-saving treatments to patients and improving outcomes for those with inflammatory conditions."
The companies' strategic partnership, formed in 2020, focuses on developing and commercializing biosimilars, with Teva handling U.S. commercialization. The success of AVT05 builds on recent approvals of other biosimilars, such as SIMLANDI and SELARSDI.
ALVO closed Friday's (Jan.24, 2025) trading at $12.99 down 0.99%.
TEVA closed Friday's (Jan.24, 2025) trading at $21.68 down 0.50%. In premarket trading Monday, the stock is down 0.88% at $21.49.
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