RESUMO
The development of 'follow on' or 'me too' drugs - generally defined as a drug with a similar chemical structure or the same mechanism of action as a drug that is already marketed - has attracted contrasting views. Some have argued that follow-on drugs often provide useful alternative or enhanced therapeutic options for particular patients or patient subpopulations, as well as introducing price competition. Others, however, consider that the development of such drugs is duplicative and that the resources needed would be better directed elsewhere. Implicit in some of this criticism is the notion that the development of me-too drugs is undertaken after a first-in-class drug has made it to market and proved commercially successful. In this Perspective, using analysis of development and patent filing histories of entrants to new drug classes in the past five decades, we provide new evidence that the development of multiple new drugs in a given class is better characterized as a race, rather than the imitation of successful products.
Assuntos
Desenho de Fármacos , Indústria Farmacêutica/economia , Competição Econômica , Aprovação de Drogas , Indústria Farmacêutica/métodos , Humanos , Patentes como Assunto , Preparações Farmacêuticas/economia , Estados Unidos , United States Food and Drug AdministrationAssuntos
Monitoramento de Medicamentos/métodos , Cooperação Internacional/legislação & jurisprudência , Internacionalidade/legislação & jurisprudência , Farmacoepidemiologia/legislação & jurisprudência , Vigilância de Produtos Comercializados , Gestão de Riscos/métodos , União Europeia , Regulamentação Governamental , Humanos , Japão , Farmacoepidemiologia/métodos , Segurança , Estados Unidos , United States Food and Drug AdministrationRESUMO
Most monoclonal antibodies in clinical trials are owned by small biotech companies. But with blockbuster-sized revenues and approval rates higher than those for small-molecule drugs, that all may be set to change.
