Importance of manufacturing consistency of the glycosylated monoclonal antibody adalimumab (Humira®) and potential impact on the clinical use of biosimilars

Author byline as per print journal: Professor Paul J Declerck, PhD; Paul W Tebbey, PhD Abstract: The clinical performance of biological therapies is affected by their manufacturing processes. The advent of biosimilars increases the need to understand the clinical impact of potential differences versus originator products. This paper reviews important recently published technical data on […]


Payer and physician evidence and discount requirements for biosimilars in three Latin American countries

Study objectives: In Latin America, many governments have attempted to address biosimilar safety and efficacy concerns by developing abbreviated regulatory pathways to increase access while controlling quality. This study explores discount and evidence requirements for payers and physicians to provide access to and prescribe biosimilars in Argentina, Brazil and Mexico. Methods: We conducted targeted literature […]


The case for biosimilars–a payer’s perspective

Abstract:  Biosimilars have the potential for making savings in healthcare costs, and with resource allocation, if competition is permitted at the level of treatment induction. Submitted: 24 August 2012; Revised: 17 January 2013; Accepted: 4 February 2013; Published online first: 13 February 2013 The last decade or so has seen the introduction of many truly innovative biological pharmaceuticals that have had a […]