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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.

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