Equivalent Recombinant Human Insulin Preparations and their Place in Therapy

Abstract

Recombinant human insulin was one of the first products of biotechnology. It was developed in response to the need for a consistent and sufficient worldwide supply. Recombinant human insulin replaced the animal insulins and semisynthetic insulins obtained by modification of animal insulins. Bioequivalence studies were required for regulatory approval. Three reference products were independently established during these procedures: Humulin® (Eli Lilly and Co), Novolin® (NovoNordisk) and Insuman® (Sanofi). Numerous brand names have been used during the commercial development of recombinant human insulin formulations. In this review, three current brand names are used for consistent identification. Human insulin for Humulin and Insuman are produced by fermentation in bacteria () and for Novolin in yeast (). The bioequivalence of recombinant human insulin products was investigated in euglycaemic clamp studies. An overview of such bioequivalence studies is provided here. This paper will consider the relevance of human insulin formulations today and their place in therapy.

Availability and Pharmacoeconomics of Insulin Therapy in Countries with the Largest Number of Diabetics

“…Experts predict that due to the prolonging life expectancy of diabetics, the gradually increasing dose requirements, and new cases of DM, the rI sales will increase [25,[27][28][29][31][32][33][34]. The above factors together with the growing production of biosimilars may change the insulin market segmentation in the way it happened in 2015 with the basal insulin analogues.…”

“…Obtaining the active pharmaceutical ingredient (API) of insulin from cultured cells is a complex and expensive multi-step process e associated with organizational measures to meet the requirements of EP/EMA or UP/FDA and to allow this product to be used for injection [24,27,29,33]. To date, several technologies with some different characteristics have been developed to produce the rI on an industrial scale [31,33, Данная интернет-версия статьи была скачана с сайта http://www.pharmacoeconomics.ru.…”

Producción de proteínas recombinantes a partir de animales transgénicos: Sistemas y aplicaciones

“…En 1982, la Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) aprobó el uso del primer fármaco producido por medio de la tecnología del ADN recombinante, utilizando esta bacteria. Dicho fármaco fue denominado Humulin®, el cual es una insulina basal de efecto prolongado/intermedio [9]. Para el proceso de producción de proteínas recombinantes es necesario utilizar enzimas de restricción.…”

Biosimilar insulins: Informed choice for South Asia

“…This has been achieved by using recombinant deoxyribonucleic acid technology, with either bacteria ( Escherichia coli ) or yeast ( Saccharomyces cerevisiae, Pichia pastoris ) as host. [ 1 ] The use of these living organisms, as vectors for insulin synthesis, classifies insulin, along with other hormones, like a biological product [ Table 1 ]. Enhanced awareness about the “therapeutic triad” (efficacy, safety, and tolerability) has prompted stringent regulatory processes, which ensure that no innovator biological molecule reaches the customer without going through a robust preclinical and clinical development program.…”