The American College of Rheumatology (ACR) has published a new white paper, “The Science Behind Biosimilars – Entering a New Era of Biologic Therapy,” providing a comprehensive overview of the scientific, clinical, economic and prescribing issues pertaining to biosimilar use, including efficacy, competition and drug pricing. The paper encourages providers to incorporate these drugs into treatment plans of patients with rheumatic diseases where appropriate.
The FDA has approved nine biosimilar medications, six of which are for treatment of rheumatic diseases, since the Biologics Price Competition and Innovation Act (BPCI Act) of 2009 was passed in an effort to reduce costs and increase patient’s access to biologics. As biosimilar usage increases, an extensive discussion about issues regarding immunogenicity, switching, and patient access has emerged. New recommendations for clinical practice have been made, based on continued evaluation from regulatory agencies and successful administration of biosimilars in Europe. Over the past few years, the ACR has voiced its support for FDA approval measures to ensure the safety of biosimilars as they become available in the U.S. market, including a proposal to require manufacturers to use robust switching studies and support for distinct naming conventions and billing codes to make post-marketing surveillance easier.
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