European medicines agency confirms acceptance of marketing authorization application for avt05, a proposed biosimilar to simponi® (golimumab)

Alvotech (nasdaq: alvo), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and advanz pharma, a uk headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in europe, today announced that the european medicines agency (ema) has accepted a marketing authorization application for avt05, alvotech's proposed biosimilar to simponi® (golimumab),  a biologic used to treat several chronic inflammatory diseases. this is believed to be the first marketing authorization application filing announced globally for a biosimilar candidate to simponi. the approvals process is anticipated to be completed in the fourth quarter of 2025. "this is a welcome milestone for us, our partners, patients and caregivers, as we take one step closer to being able to offer access to biosimilar simponi®," said joseph mcclellan, chief scientific officer of alvotech. “we believe having the capability and know-how inhouse to utilize a host cell line and process also used to manufacture the reference biologic, has given us an important head start in developing a biosimilar candidate to simponi®." “the ema's acceptance of the application for avt05 represents a significant step forward in expanding treatment options for patients with chronic inflammatory diseases across europe,” said nick warwick, chief medical officer of advanz pharma. “we are committed to improving patient access to high-quality biologic medicines.” alvotech and advanz pharma first announced in february 2023 that the companies had entered into a commercialization agreement, for avt23, a proposed biosimilar to xolair® (omalizumab). in may this year, the partners announced an expansion of the strategic partnership, to include five additional biosimilar candidates being developed by alvotech, avt05, avt16 a proposed biosimilar to entyvio® (vedolizumab) and three additional early-stage biosimilar candidates which remain undisclosed. 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. 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.
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