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Adalimumab-Adbm: The First Interchangeable Biosimilar for the Treatment of Inflammatory Diseases. | LitMetric

Adalimumab-Adbm: The First Interchangeable Biosimilar for the Treatment of Inflammatory Diseases.

Ann Pharmacother

Department of Pharmacy and Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL, USA.

Published: December 2022

AI Article Synopsis

  • The study reviews the pharmacologic and clinical profile of adalimumab-adbm, the first interchangeable biosimilar for treating inflammatory diseases like Crohn's disease and rheumatoid arthritis.
  • Approval for adalimumab-adbm was based on phase 3 VOLTAIRE trials that showed it has comparable efficacy and safety to the reference drug, with common side effects including infections and injection site reactions.
  • This biosimilar aims to improve patient access and reduce costs, though it won't be available until 2023 and may encounter adoption challenges similar to other biosimilars.*

Article Abstract

Objective: The objective of the study was to review the pharmacologic and clinical profile of adalimumab-adbm (BI 695501), the first interchangeable biosimilar for treatment of inflammatory diseases.

Data Sources: A PubMed search was conducted from inception to December 2021 using the keywords and . Information was also obtained from published abstracts and package inserts.

Study Selection And Data Extraction: Phase 1, 2 and 3 studies plus relevant literature on adalimumab-adbm pharmacologic and clinical profile were reviewed.

Data Synthesis: Adalimumab-adbm approval was based on a series of phase 3 VOLTAIRE trials, which evaluated the biosimilar's efficacy and safety in the treatment of moderate to severe Crohn's disease, rheumatoid arthritis, and psoriasis. Interchangeability status was granted based on data from the VOLTAIRE-X trial. The VOLTAIRE and VOLTAIRE-X studies demonstrated comparable efficacy and safety between adalimumab-adbm and reference adalimumab. Common adverse events included infections and injection site reactions. Similar to reference adalimumab, adalimumab-adbm contains black box warnings related to serious infections and malignancy.

Relevance To Patient Care And Clinical Practice: Adalimumab-adbm is the first interchangeable biosimilar to be approved for inflammatory diseases and has the potential to improve patient access to treatment while decreasing medication-related costs. However, it will not be commercially available for patient use until 2023 and its adoption into clinical practice may face potential barriers seen with other biosimilars.

Conclusion: As an interchangeable biosimilar with comparable efficacy and safety to reference adalimumab, adalimumab-adbm is an important advance toward cost-effective management of inflammatory diseases.

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Source
http://dx.doi.org/10.1177/10600280221082196DOI Listing

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