Monoclonal Antibodies for Therapeutic Use: Specific Characteristics of Clinical Development, Evaluation by the Agencies, and Long-term Monitoring of Safety

¹ François Rabelais University Tours; CNRS UMR 7292; CHRU of Tours, Pharmacology-Toxicology Laboratory, Tours, France
² Amgen, France
³ Afssaps, France

Correspondence and offprints: Gilles Paintaud, Pharmacology-Toxicology Laboratory and CNRS UMR 7292, CHRU of Tours, 2 boulevard Tonnellé, F-37044 Tours Cedex 9, France. Email: Cette adresse e-mail est protégée contre les robots spammeurs. Vous devez activer le JavaScript pour la visualiser.

Received: 20 March 2012
Accepted: 4 June 2012

Abstract

Monoclonal antibodies (MoAb) are very different from other drugs. The Round Table aimed to determine whether the specific characteristics of MoAb have repercussions on their clinical development, evaluation by the health authorities, and long-term monitoring. As regards the structure-activity relationship of MoAb, classification according to mechanism of action (neutralising or agonist MoAb, cytolytic MoAb) is more relevant than to their degree of humanisation. Recommendations on their clinical development would be useful since the early phases give rise to a number of problems and are insufficiently codified. The pharmacokinetic profile is very different from that of other drugs. The concentration-effect relationship is difficult to study since the biomarkers may be apparently disconnected from the therapeutic effect. The methodology for evaluation of MoAb by the agencies, and postmarketing surveillance do not differ from the procedures used for other drugs; however, MoAb bring together a number of specific characteristics as compared with other drugs.