Over the last few years various therapeutic proteins, also called biologicals, have been brought on the market, including the monoclonal antibodies against TNFα (infliximab, adalimumab, etanercept) and CD20 (rituximab). Preferentially, the term biopharmaceuticals is nowadays used for these latter therapeutic proteins. Biopharmaceuticals are then defined as medical drugs produced using biotechnology. They are proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source.
Biologicals seems warranted for two reasons. Firstly, WHO has always been deeply concerned about quality assurance and safety of blood products and related biologicals and the Organization has continuously stressed that only blood products of demonstrated quality, safety and efficacy should be used. However there is a fear that especially countries with limited resources have significant difficulties in fulfilling their responsibilities in this field. Secondly, the ever increasing importance of biopharmaceuticals in medicine in itself was reason enough for this book edition.