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Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study.
Wiland P, Jeka S, Dokoupilová E, Brandt-Jürgens J, Miranda Limón JM, Cantalejo Moreira M, Cabello RV, Jauch-Lembach J, Thakur A, Haliduola H, Brueckmann I, Gaylis NB. Wiland P, et al. Among authors: haliduola h. BioDrugs. 2020 Dec;34(6):809-823. doi: 10.1007/s40259-020-00447-6. BioDrugs. 2020. PMID: 33119861 Free PMC article. Clinical Trial.
GP2017, an adalimumab biosimilar: pharmacokinetic similarity to its reference medicine and pharmacokinetics comparison of different administration methods.
von Richter O, Lemke L, Haliduola H, Fuhr R, Koernicke T, Schuck E, Velinova M, Skerjanec A, Poetzl J, Jauch-Lembach J. von Richter O, et al. Among authors: haliduola h. Expert Opin Biol Ther. 2019 Oct;19(10):1075-1083. doi: 10.1080/14712598.2019.1571580. Epub 2019 Jan 30. Expert Opin Biol Ther. 2019. PMID: 30698045 Clinical Trial.
Differences in immunogenicity associated with non-product related variability: insights from two pharmacokinetic studies using GP2017, an adalimumab biosimilar.
von Richter O, Lemke L, Haliduola H, Balfour A, Zehnpfennig B, Skerjanec A, Jauch-Lembach J. von Richter O, et al. Among authors: haliduola h. Expert Opin Biol Ther. 2019 Oct;19(10):1057-1064. doi: 10.1080/14712598.2019.1603959. Epub 2019 Apr 19. Expert Opin Biol Ther. 2019. PMID: 31002537 Clinical Trial.
Ex vivo comparative immunogenicity assessment (EVCIA) to determine relative immunogenicity in chronic plaque psoriasis in participants receiving Humira® or undergoing repeated switches between Humira® and AVT02.
Richter K, Haliduola HN, Schockaert J, Mazy A, Reznichenko N, Guenzi E, Berti F. Richter K, et al. Among authors: haliduola hn. Immunother Adv. 2023 Dec 21;4(1):ltad029. doi: 10.1093/immadv/ltad029. eCollection 2024. Immunother Adv. 2023. PMID: 38268817 Free PMC article.
Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis.
Feldman SR, Reznichenko N, Berti F, Duijzings P, Ruffieux R, Otto H, Haliduola HN, Leutz S, Stroissnig H. Feldman SR, et al. Among authors: haliduola hn. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):759-771. doi: 10.1080/14712598.2023.2235263. Epub 2023 Jul 12. Expert Opin Biol Ther. 2023. PMID: 37435850 Clinical Trial.
A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in healthy adults.
Wynne C, Hamilton P, McLendon K, Stroissnig H, Smith M, Duijzings P, Ruffieux R, Otto H, Sattar A, Haliduola HN, Leutz S, Berti F. Wynne C, et al. Among authors: haliduola hn. Expert Opin Investig Drugs. 2023 May;32(5):417-427. doi: 10.1080/13543784.2023.2215426. Epub 2023 May 23. Expert Opin Investig Drugs. 2023. PMID: 37212315 Clinical Trial.
Assessing the Interchangeability of AVT02 and Humira® in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study.
Feldman SR, Kay R, Reznichenko N, Sobierska J, Dias R, Otto H, Haliduola HN, Sattar A, Ruffieux R, Stroissnig H, Berti F. Feldman SR, et al. Among authors: haliduola hn. BioDrugs. 2023 Jul;37(4):551-567. doi: 10.1007/s40259-023-00600-x. Epub 2023 May 19. BioDrugs. 2023. PMID: 37204631 Free PMC article. Clinical Trial.
Assessment of real-life patient handling experience of AVT02 administered subcutaneously via autoinjector in patients with moderate to severe active rheumatoid arthritis: an open-label, single-arm clinical trial, then an extension phase of AVT02 administered with a prefilled syringe.
Damjanov N, Kirvalidze N, Kurashvili N, Berti F, Steiger M, Sobierska J, Guenzi E, Otto H, Sattar A, Haliduola HN, Edwald E, Stroissnig H. Damjanov N, et al. Among authors: haliduola hn. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):781-789. doi: 10.1080/14712598.2022.2131392. Epub 2022 Oct 26. Expert Opin Biol Ther. 2023. PMID: 36205514
14 results