On 13 November 2024, Alvotech announced its financial results for the first 9 months of 2024, reporting an increase in total revenues of US $300 million and an over four-fold increase in product revenue, year on year.
Product development highlights for the year to date include the EMA acceptance of marketing authorisation applications for AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva® in October 2024, and AVT05 (golimumab), biosimilar to Janssen’s Simponi®, in November 2024. Alvotech has commercialisation agreements for European markets with STADA and Dr Reddy’s in relation to AVT03 and with Advanz Pharma in relation to AVT05.
In October 2024, the US FDA also approved a new presentation of Alvotech and Teva’s Selarsdi®/AVT04 (ustekinumab-aekn), biosimilar to Janssen’s Stelara®, in a 130 mg/26mL single-dose vial for IV infusion and a label expansion to include treatment for Crohn’s disease and ulcerative colitis. Alvotech expects a February 2025 US launch for Selarsdi®.
A further highlight is said to be Alvotech’s commencement in September 2024 of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis.
Alvotech reports licence and other revenue for the first 9 months of 2024 totalling US$210.5 million, primarily attributable to R&D milestones for the approval of AVT04/Uzpruvo® (ustekinumab) in Europe in January 2024, the commencement of the AVT16 (vedolizumab) clinical trials, European MAA submissions for AVT03 (denosumab) and AVT06 (aflibercept), and confirmatory efficacy and safety trials completed for AVT03 (denosumab) and AVT05 (golimumab). There was also achievement of a performance milestone for the product launch of AVT04 (ustekinumab) in Japan (as Ustekinumab BS (F)) and Europe (as Uzpruvo®), a sales target for AVT02 (adalimumab) in Europe and Canada, and a product launch of AVT02 (as Simlandi®) in the US.