Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab)

In This Article:

Alvotech
Alvotech

REYKJAVIK, Iceland and PARSIPPANY, N.J., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab), which are prescribed to treat a variety of inflammatory conditions. These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. The FDA review process for these applications is anticipated to be completed in the fourth quarter of 2025.

"This is a significant step towards being able to offer U.S. patients access to biosimilar golimumab," said Joseph McClellan, Chief Scientific Officer of Alvotech. “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."

Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, added, “Biosimilars are ushering a new treatment paradigm and have become an integral staple in the healthcare ecosystem. Teva’s strategic partnership with Alvotech underscores our commitment to continue to bring cost-saving options to more patients and deliver better outcomes for those with inflammatory conditions.”

In April 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between AVT05 and Simponi® in patients with moderate to severe rheumatoid arthritis. Previously, in November 2023, Alvotech announced positive topline results from a pharmacokinetic study which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® in healthy adult participants.

In August 2020, Alvotech and Teva entered into a strategic partnership for the exclusive commercialization of five of Alvotech’s biosimilar product candidates, including AVT05. The partnership has since expanded and now includes a total of nine products. Alvotech handles development and manufacturing using its purpose-built end-to-end platform, while Teva is responsible for commercialization in the U.S., which leverages Teva’s experience and extensive sales and marketing infrastructure.