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The Need for Biosimilars in Inflammatory Diseases and Regulatory Requirements for Approval
Drs Lio, Botsoglou, and Alexrad discuss the need for biosimilars in inflammatory diseases, and clinical pharmacist Dr Humphreys reviews the regulatory requirements for biosimilars to receive FDA approval.
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.
Experts discuss the role of biologic agents and biosimilars in managing chronic inflammatory diseases. The advent of biologics has significantly improved patients' lives, and biosimilars offer increased access to these therapies. With a growing array of options, practitioners are identifying and treating patients earlier in the disease progression.
The speaker highlights the importance of biosimilars, which are vital for managing formularies in large healthcare systems like Sutter Health. They emphasize the transformative impact of these therapies in dermatology and underscores the need for cost-effective solutions to broaden access.
The speaker explains the regulatory requirements for biosimilars under the Biologic Price Competition and Innovation Act (BPCIA). While biosimilars are highly similar to reference products, they cannot be substituted at the pharmacy level without physician approval. Formulary decisions within health systems help streamline prescribing practices.
Overall, the exchange emphasizes the significance of biosimilars in expanding access to effective treatments for inflammatory diseases while navigating regulatory complexities and cost considerations.
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.
