Publications by authors named "Fausto Berti"

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Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study.
Monica Luque, Kristina Zhelyazkova, Laxmikant Vashishta, Masna Rai, Abid Sattar, Fausto Berti

BioDrugs· November 2025

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Pharmacokinetic Similarity of Biosimiliar AVT05 Versus Reference Product Golimumab in Healthy Adults: A Double-Blind, Three-Arm, Parallel-Group Study.
Chris Wynne, Ulrike Lorch, Edrich Krantz, Rohit Katial, Thomas Ashdown, Fausto Berti

BioDrugs· November 2025

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A randomized, double blind, parallel design, repeat dose, 2-arm, multicenter study comparing the efficacy, safety, immunogenicity, and pharmacokinetic profiles of a denosumab biosimilar, AVT03, in postmenopausal women with osteoporosis.
Mamuka Lortkipanidze, Tobie de Villiers, Grzegorz Kania, Felicitas Bullo, Lukasz Jaskiewicz, Fausto Berti

Expert Opin Biol Ther· August 2025

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A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration.
Hansjürgen Agostini, Kristine Baumane, Vilma Jūratė Balčiūnienė, Kaspars Ozols, Riken Soni, Fausto Berti

Expert Opin Biol Ther· July 2025

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A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, pharmacodynamic, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (60 mg/mL) in healthy male adults.
Anel Pretorius, Felicitas Bullo, Lukasz Jaskiewicz, Serena Stamatakos, Hendrik Otto, Fausto Berti

Expert Opin Investig Drugs· June 2025

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A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (70 mg/mL) in healthy male adults.
Monika Tomaszewska-Kiecana, Felicitas Bullo, Lukasz Jaskiewicz, Serena Stamatakos, Hendrik Otto, Fausto Berti

Expert Opin Investig Drugs· June 2025

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The totality of evidence approach in the development of AVT02 (adalimumab), a biosimilar to Humira.
Joseph E McClellan, Sesselja Ómarsdóttir, Nivedita Roy, Verena Berger, Cecilia Michel, Fausto Berti

Ther Adv Chronic Dis· January 2024

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comparative immunogenicity assessment (EVCIA) to determine relative immunogenicity in chronic plaque psoriasis in participants receiving Humira or undergoing repeated switches between Humira and AVT02.
Kathleen Richter, Halimu N Haliduola, Jana Schockaert, Aurélie Mazy, Nataliya Reznichenko, Fausto Berti

Immunother Adv· December 2023

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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.
Steven R Feldman, Nataliya Reznichenko, Fausto Berti, Paul Duijzings, Ruth Ruffieux

Expert Opin Biol Ther· November 2023

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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.
Steven R Feldman, Richard Kay, Nataliya Reznichenko, Joanna Sobierska, Roshan Dias, Fausto Berti

BioDrugs· July 2023

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A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in healthy adults.
Christopher Wynne, Paul Hamilton, Kristi McLendon, Heimo Stroissnig, Matthew Smith, Fausto Berti

Expert Opin Investig Drugs· May 2023

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A multicenter, randomized, open-label, 2-arm parallel study to compare the pharmacokinetics, safety and tolerability of AVT02 administered subcutaneously via prefilled syringe or autoinjector in healthy adults.
Christopher Wynne, Christian Schwabe, Heimo Stroissnig, Roshan Dias, Joanna Sobierska, Fausto Berti

Expert Opin Biol Ther· October 2022

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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.
Nemanja Damjanov, Nana Kirvalidze, Nana Kurashvili, Fausto Berti, Matjaz Steiger

Expert Opin Biol Ther· October 2022

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Joint analysis of PK and immunogenicity outcomes using factorization model - a powerful approach for PK similarity study.
Halimu N Haliduola, Fausto Berti, Heimo Stroissnig, Eric Guenzi, Hendrik Otto

BMC Med Res Methodol· October 2022

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A randomized, adaptive design, double-blind, 3-arm, parallel study assessing the pharmacokinetics and safety of AVT02, a high-concentration (100 mg/mL) Adalimumab biosimilar, in healthy adult subjects (ALVOPAD FIRST).
Christopher Wynne, Christian Schwabe, Charlotte Lemech, Heimo Stroissnig, Roshan Dias, Fausto Berti

Expert Opin Investig Drugs· September 2022

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Efficacy, Safety and Immunogenicity of AVT02 Versus Originator Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis: A Multicentre, Double-Blind, Randomised, Parallel Group, Active Control, Phase III Study.
Steven R Feldman, Nataliya Reznichenko, Grazyna Pulka, Külli Kingo, George Galdava, Fausto Berti

BioDrugs· November 2021

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Effect of sulforaphane on micronucleus induction in cultured human lymphocytes by four different mutagens.
Carmela Fimognari, Fausto Berti, Giorgio Cantelli-Forti, Patrizia Hrelia

Environ Mol Mutagen· December 2005

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In vitro antitumor activity of cyanidin-3-O-beta-glucopyranoside.
Carmela Fimognari, Fausto Berti, Michael Nusse, Giorgio Cantelli Forti, Patrizia Hrelia

Chemotherapy· October 2005

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In vitro anticancer activity of cyanidin-3-O-beta-glucopyranoside: effects on transformed and non-transformed T lymphocytes.
Carmela Fimognari, Fausto Berti, Michael Nüsse, Giorgio Cantelli-Fortii, Patrizia Hrelia

Anticancer Res· September 2005

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A mutated p53 status did not prevent the induction of apoptosis by sulforaphane, a promising anti-cancer drug.
Carmela Fimognari, Luca Sangiorgi, Silvia Capponcelli, Michael Nüsse, Silvia Fontanesi, Fausto Berti

Invest New Drugs· June 2005

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Micronucleus formation and induction of apoptosis by different isothiocyanates and a mixture of isothiocyanates in human lymphocyte cultures.
Carmela Fimognari, Fausto Berti, Renato Iori, Giorgio Cantelli-Forti, Patrizia Hrelia

Mutat Res· April 2005

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Isothiocyanates as novel cytotoxic and cytostatic agents: molecular pathway on human transformed and non-transformed cells.
Carmela Fimognari, Michael Nüsse, Fausto Berti, Renato Iori, Giorgio Cantelli-Forti

Biochem Pharmacol· September 2004

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Induction of apoptosis in two human leukemia cell lines as well as differentiation in human promyelocytic cells by cyanidin-3-O-beta-glucopyranoside.
Carmela Fimognari, Fausto Berti, Michael Nüsse, Giorgio Cantelli-Forti, Patrizia Hrelia

Biochem Pharmacol· June 2004

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Effect of cyanidin 3-O-beta-glucopyranoside on micronucleus induction in cultured human lymphocytes by four different mutagens.
Carmela Fimognari, Fausto Berti, Giorgio Cantelli-Forti, Patrizia Hrelia

Environ Mol Mutagen· March 2004

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Sulforaphane modulates cell cycle and apoptosis in transformed and non-transformed human T lymphocytes.
Carmela Fimognari, Michael Nüsse, Fausto Berti, Renato Iori, Giorgio Cantelli-Forti

Ann N Y Acad Sci· December 2003

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