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 2024, 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 June 2024, the partners announced that they had entered into a commercialization agreement for AVT06, a proposed biosimilar to Eylea® low dose (2 mg) and AVT29, a biosimilar candidate for Eylea® high dose (8 mg). 
 

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.

About AVT05 
AVT05 is a biosimilar candidate for Simponi^® and Simponi Aria^® (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [1]. AVT05 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

About AVT16 
AVT16 is a human monoclonal antibody and a biosimilar candidate to Entyvio^® (vedolizumab). AVT16 is an investigational product and has not received regulatory approval in any country. Biosimiliarity has not been established by regulatory authorities and is not claimed.

About AVT06/AVT29
AVT06/AVT29 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept), which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. AVT06/AVT29 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

About AVT23
AVT23 is a monoclonal antibody and proposed biosimilar to Xolair^® (omalizumab). AVT23 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.