Introduction: Biosimilars have transformed treatment modalities across various medical fields such as oncology, rheumatology, and immunology. Despite their potential for reducing healthcare costs, concerns persist regarding their ability to induce an immune response, which could affect efficacy and safety. This review critically evaluates the current evidence on the immunogenicity of biosimilars and discusses the regulatory frameworks guiding their approval and monitoring.
Areas Covered: This review includes studies from databases like Scopus, PubMed, Web of Science, and ScienceDirect, published up to April 2024. It explores the 'totality of the evidence' approach used by regulatory bodies like the FDA and EMA, detailing analytical, preclinical, and clinical assessments that ensure biosimilars' similarity to their reference products in terms of structure, function, and clinical outcomes. The review also addresses the challenges and limitations in current research methodologies and the implications of immunogenicity on therapeutic efficacy and patient safety.
Expert Opinion: While substantial evidence confirms the safety and efficacy of biosimilars, the review emphasizes the need for continuous regulatory vigilance and advanced methodologies in post-marketing surveillance to capture long-term immunogenicity data effectively. It advocates for integrating cutting-edge analytical techniques and personalized medicine to better manage immunogenic risks associated with biological therapies.
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http://dx.doi.org/10.1080/14740338.2025.2467817 | DOI Listing |
Eur J Clin Pharmacol
March 2025
Department of Public Health, College of Health Sciences, Abu Dhabi University, Abu Dhabi, United Arab Emirates.
Background: The adoption of generic and biosimilar medications is crucial for improving healthcare accessibility and cost savings in the Middle East and North Africa (MENA) region. Understanding the factors that influence their acceptance is crucial for developing effective strategies for promoting their use.
Purpose: This systematic review aimed to examine the facilitators and barriers identified by healthcare professionals while prescribing and dispensing generic and biosimilar medications in the MENA region, focusing on their perceptions, knowledge, and attitudes.
Front Immunol
March 2025
Pharmacokinetics, Dynamics and Metabolism, Pfizer Inc., Andover, MA, United States.
Introduction: Unwanted immune responses (UIRs) to biologics can negatively impact treatment efficacy and pharmacokinetics and/or induce adverse events (AEs). We characterized the UIR profile of adalimumab (ADL) using data from a phase 3, randomized, interchangeability study of reference ADL (ADL-REF; Humira) and ADL biosimilar PF-06410293 in patients with rheumatoid arthritis (RA).
Methods: Eligible patients (18-70 years, moderate-to-severe active RA) received ADL-REF from weeks 0-10 (lead-in period) then were randomized 1:1 to: 3 switches between PF-06410293 and ADL-REF or continuous ADL-REF treatment until week 32.
J Clin Aesthet Dermatol
February 2025
Ms. Romanelli and Dr. Gottlieb are with the Department of Dermatology and Department of Medicine, Division of Rheumatology at Icahn School of Medicine at Mount Sinai in New York, New York.
Psoriasis (PsO) is an immune-mediated, chronic inflammatory skin disease that significantly impairs quality of life. Its treatment landscape is rapidly evolving, providing better disease control. Here, we highlight updates in biologics, obtaining coverage for biologics under Medicare, the PsO-to-psoriatic arthritis (PsA) transition, and orally administered drugs, as presented at the 2024 Masterclass in Dermatology in Puerto Rico.
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