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

Article Pharmacology & Pharmacy

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 et al.

Summary: This study assessed the bioequivalence, safety, and immunogenicity of AVT02 compared with reference product adalimumab. The results demonstrated bioequivalence between AVT02 and the reference product, and showed similar safety and immunogenicity profiles in all three treatment arms.

EXPERT OPINION ON INVESTIGATIONAL DRUGS (2022)

Add to Collection

Article Medicine, General & Internal

A Patients' Perspective Towards the Injection Devices for Humira® and Imraldi® in a Nationwide Switching Program

Kristin Karlsdottir et al.

Summary: In a study conducted in Iceland on the switching of patients from Humira(R) to Imraldi(R), most patients preferred the Humira(R) injection device. The majority found the Imraldi(R) pen more difficult to use, citing reasons such as more painful needle insertion and differences in the injection process. Overall, the results highlight the importance of providing thorough information and individualized instruction when switching to biosimilars.

FRONTIERS IN MEDICINE (2022)

Add to Collection

Article Oncology

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 et al.

Summary: This study aimed to compare the efficacy, safety, and immunogenicity of AVT02 versus Humira(R) in subjects with chronic plaque psoriasis. The results showed that AVT02 demonstrated comparable efficacy, safety, and immunogenicity profiles to the originator drug at Week 16 and Week 50, supporting the evaluation of biosimilarity between AVT02 and originator adalimumab.

BIODRUGS (2021)

Add to Collection

Review Chemistry, Medicinal

Overview of Humira® Biosimilars: Current European Landscape and Future Implications

Jill Coghlan et al.

Summary: With the introduction of adalimumab biosimilars in the European market, the sales of Humira (R) started to decline, with nearly 35% of patients switching to biosimilars. As the adoption of biosimilars increases in Europe and Humira (R) loses its patent protection in 2023, diminishing sales are expected to continue.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

Add to Collection

Article Pharmacology & Pharmacy