Long-term efficacy, safety and tolerability data for the AVT04 ustekinumab biosimilar candidate developed in partnership by Alvotech and STADA corroborate the finding of therapeutic equivalence to the Stelara® reference product in patients with moderate-to-severe chronic plaque psoriasis (PsO) in the primary endpoint at Week 12.
Data from long-term follow-up outcomes over 52 weeks were presented in a poster during the European Academy of Dermatology and Venereology (EADV) Congress held in Berlin, Germany, on 11‒14 October 2023.
A phase III study was designed to demonstrate the therapeutic equivalence between AVT04 and the reference product in participants with moderate-to-severe chronic PsO [1, 2].
This multicentre, double-blind study randomized participants in a 1:2 (AVT04:RP) ratio. Participants in the reference-product group were re-randomized 1:1 at Week 16 to either continue receiving the reference product, or switch to AVT04.
For all groups in this long-term study, the percentage improvement in Psoriasis Area and Severity Index (PASI) score observed at Week 12 persisted through Week 52. This includes participants who switched.
The safety profiles remained similar across both treatment arms including after the treatment switch. The immunogenicity of both AVT04 and Stelara had no clinically significant impact on their efficacy, safety, or pharmacokinetic profiles.
A complete report of data from the 52-week read-out of the study has recently been published as a manuscript by Wynne et al. [3].
These long-term data confirm the initial results of this study – namely that AVT04 and the reference product had similar efficacy, safety, tolerability, and pharmacokinetics up to Week 28 – which were presented at the American Academy of Dermatology Annual Meeting in New Orleans, USA on 17–21 March 2023.
Marketing authorization applications for AVT04 have been submitted in major markets around the world. In September 2023, Japan’s Ministry of Health, Labor and Welfare became the first global authority to approve AVT04 as the world’s first ustekinumab biosimilar referencing Stelara [4, 5].
In Europe, Alvotech and STADA announced in February 2023 that the European Medicines Agency had confirmed acceptance of an application for AVT04 [6, 7]. The partners anticipate that the Committee for Medicinal Products for Human Use positive opinion on AVT04 will be received during the second half of 2023.
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References
1. National Library of Medicine. Efficacy, safety, and immunogenicity of AVT04 With moderate-to-severe chronic plaque psoriasis [homepage on the Internet]. [cited 2023 Oct 17]. Available from: https://www.clinicaltrials.gov/study/NCT04930042
2. EU Clinical Trials Register [homepage on the Internet]. [cited 2023 Oct 17]. Available from: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004493-22/PL
3. Wynne C, Hamilton P, McLendon K, et al. A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in healthy adults. Expert Opin Investig Drugs. 2023;32(5):417-27.
4. Alvotech. Alvotech announces approval in Japan of AVT04 (ustekinumab), a biosimilar to Stelara® [homepage on the Internet]. [cited 2023 Oct 17]. Available from: https://investors.alvotech.com/news-releases/news-release-details/alvotech-announces-approval-japan-avt04-ustekinumab-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for first ustekinumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 17]. Available from: www.gabionline.net/biosimilars/news/japanese-approval-for-first-ustekinumab-biosimilar
6. Stada. EMA confirms acceptance of application for AVT04 a proposed biosimilar to Stelara ustekinumab [homepage on the Internet]. [cited 2023 Oct 17]. Available from: https://www.stada.com/blog/posts/2023/february/ema-confirms-acceptance-of-application-for-avt04-a-proposed-biosimilar-to-stelara-ustekinumab
7. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for ustekinumab biosimilar AVT04 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 17]. Available from: www.gabionline.net/biosimilars/news/ema-accepts-application-for-ustekinumab-biosimilar-avt04
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