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

FDA Review and Biosimilar Development - The FDA has accepted Biologics License Applications (BLA) for AVT05, Alvotech's proposed biosimilar to Simponi and Simponi Aria (golimumab), with the review process expected to be completed in Q4 2025 [1] - AVT05 is the first biosimilar candidate to golimumab to have its BLA filings accepted in the U S [1] - Alvotech's in-house capability to match the cell line and process used to manufacture the reference biologic has provided a significant advantage in developing AVT05 [2] Strategic Partnership and Commercialization - Alvotech and Teva Pharmaceuticals entered into a strategic partnership in August 2020 for the exclusive commercialization of five biosimilar product candidates, which has since expanded to include nine products [3] - Under the partnership, Alvotech handles development and manufacturing, while Teva is responsible for commercialization in the U S [3] - Two biosimilars developed under the partnership, SIMLANDI (adalimumab-ryvk) and SELARSDI (ustekinumab-aekn), have already received FDA approval [4] Clinical and Regulatory Progress - Alvotech announced positive top-line results from a confirmatory clinical study comparing AVT05 to Simponi in patients with moderate to severe rheumatoid arthritis in April 2024 [2] - A pharmacokinetic study comparing AVT05 to Simponi in healthy adults also showed positive results in November 2023 [2] - SIMLANDI, a biosimilar to Humira, was launched in the U S in May 2024, while SELARSDI, a biosimilar to Stelara, is planned for U S market entry in February 2025 [4] Product Pipeline and Market Reach - Alvotech's current development pipeline includes nine disclosed biosimilar candidates targeting autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer [9] - The company has formed a network of strategic commercial partnerships to provide global reach, covering markets in the U S, Europe, Japan, China, and other regions [9] - SIMLANDI and SELARSDI are already approved and marketed in multiple global markets under various brand names [6][7] Industry Impact and Future Outlook - Biosimilars are becoming an integral part of the healthcare ecosystem, offering cost-saving options and better outcomes for patients with inflammatory conditions [2] - The strategic partnership between Alvotech and Teva underscores the commitment to expanding access to biosimilars and leveraging Teva's extensive sales and marketing infrastructure [3] - The FDA's acceptance of AVT05's BLA filings marks a significant step toward providing U S patients with access to biosimilar golimumab [1][2]