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    Early Biosimilar Development: A Model for Expeditious Progress to a Phase 3 Trial

    This article discusses biosimilar clinical development and how companies are addressing the clinical development concerns associated with early biosimilar drug development. Introduction The introduction of biological medicines has had a significant impact on the health of patients suffering from many debilitating and life threatening diseases. Biological medicines have dramatically reduced disability for patients with inflammatory diseases, such as rheumatoid arthriti...
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    US Biosimilar Guidelines: Summary and Insights

    In March 2010, section 351(a) of the Public Health Service Act was amended to create an abbreviated pathway for the approval of biosimilars or interchangeable biologic products that were found to be highly similar to US Food and Drug Administration (FDA) licensed biologics. Under the act's definition, 'biosimilarity' means "the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and… ...