The European regulatory environment of rna-based vaccines

A variety of different mRNA-based drugs are currently in development. This became possible, since major breakthroughs in RNA research during the last decades allowed impressive improvements of translation, stability and delivery of mRNA. This article focuses on antigen-encoding RNA-based vaccines that are either directed against tumors or pathogens. mRNA-encoded vaccines are developed both for preventive or therapeutic purposes. Most mRNA-based vaccines are directly administered to patients. Alternatively, primary autologous cells from cancer patients are modified ex vivo by the use of mRNA and then are adoptively transferred to patients. In the EU no regulatory guidelines presently exist t…

The regulatory landscape for actively personalized cancer immunotherapies

Putting the “bio” in “biotherapeutics”/checkpoints for biosimilars/application of biosimilars

Abstract / Executive summary The number of biosimilar medicines on the market is steadily increasing, due, in part, to patent expiration of several top-selling biologic medicines. These three e-learning modules discuss the basic concepts behind biosimilar medicines and highlight key regulatory considerations when using biosimilar medicines in medical practice.