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Editor's introduction to the initial issue of the fourth volume of GaBI Journal

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This first 2015 GaBI Journal issue (fourth volume of the journal) is being published soon after the first US biosimilar approval and it contains a number of articles that illustrate how the development, marketing and acceptance of biosimilars differ globally including in North and South America and the Persian Gulf States. An Editorial entitled Biosimilars: patient and physician acceptability is the fifth hurdle to market competition by Professor Alan Lyles discusses the original research article in this issue by Sandorff et al. on regulatory requirements in three Latin American countries. Professor Lyles proposes that in addition to safety, efficacy, quality data, country specific decisions about use of and payment for biosimilars now requires both cost-effectiveness (the 'fourth hurdle') as well as acceptability information (the 'fifth hurdle'). He discusses why uptake of biosimilars requires both significant savings and trust in the approval process as well as how evidence-based decisions are evolving for biosimilars.

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