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An Overview of Adalimumab Biosimilars
Clinicians and a pharmacist provide an overview of the emerging adalimumab biosimilars in the recent years.
This is a video synopsis/summary of a panel discussion involving Jamie T. Brogan, MSN, APRN, FNP-BC; Kostas Botsoglou, MD; Jordan Axelrad, MD, MPH; Sophia Humphreys, PharmD, MHA; and Peter Lio, MD.
The discussion focuses on adalimumab biosimilars, examining their indications, mechanism of action, interchangeability, and clinical implications. Currently, there are over 40 biosimilars created for a dozen biologic products, with a focus on adalimumab. While most indications of adalimumab have biosimilar alternatives, three orphan drug indications remain unapproved for biosimilars.
The mechanism of action for adalimumab biosimilars mirrors that of the reference product, with rigorous FDA review processes ensuring structural and functional similarity. Biosimilars must demonstrate identical primary and secondary structures to reference products, differing only in tertiary and quaternary folding. Additionally, they share the same administration route and strength.
Interchangeability designation by the FDA streamlines pharmacy-level switches, but specific conditions must be met. Biosimilars must replicate clinical outcomes, maintain safety profiles, and undergo switching studies. Despite potential benefits, providers emphasize the importance of patient education and notification regarding biosimilar switches to maintain therapy continuity.
The discussion highlights the need for proactive patient communication and regulatory compliance to facilitate smooth transitions between reference and biosimilar products. Clinicians express willingness to embrace interchangeable biosimilars to reduce administrative burdens and ensure uninterrupted patient care, underscoring the importance of effective communication and documentation within healthcare systems.
Video synopsis is AI-generated and reviewed by Center for Biosimilars editorial staff.
Not So Different: Dr Gary Lyman Explains How to Ensure Physician Confidence in Biosimilars
August 15th 2021Gary Lyman, MD, MPH, an oncologist and hematologist, discusses some of the issues holding physicians back from prescribing biosimilars and some ways to ensure provider confidence in biosimilars.
Comparable Safety, Efficacy Between First Proposed Natalizumab Biosimilar, Reference for MS
March 3rd 2023Phase 3 study findings support a proposed natalizumab biosimilar (PB006) as the first biosimilar alternative to reference natalizumab (Tysabri) for treatment of relapsing-remitting multiple sclerosis (MS).
Denosumab Biosimilar Demonstrates Noninferiority to Prolia in Postmenopausal Osteoporosis
July 30th 2022Results from a phase 3 trial suggested similar efficacy and safety of the denosumab biosimilar candidate Arylia (AryoGen Pharmed) to the reference product (Prolia) in postmenopausal osteoporosis.
