chapter  21
16 Pages

In Vitro–In Vivo Correlation: Application to Biotech Product

ByDevelopment

INTRODUCTION Biotech drugs are an increasing segment of drug development in which a lot of companies ranging from start-ups to major pharmaceutical companies invest billions of Euros in the development of around 400 molecules in portfolios (1). New innovative biotech molecules, granted marketing authorization each year, are intended to treat major pathologies; around 150 of them have a marketing authorization (1). In the past years, a new segment was opened in biotech field, called biosimilar. Drugs such as somatropin, recombinant insulin, aglucerase, streptokinase, interferon (IFN)-a-2b, erythropoetin, IFN-g-1b, tPA, interleukin (IL)-2, and granulocyte colony-stimulating factor (G-CSF) are off-patent and lead to development of biosimilar.