What is a Biopharmaceutical ?

T he terms biotechnology and biopharmaceutical describe many complex and important products, technologies, R&D, and industries. Most people, particularly those within the industry, presume that a biopharmaceutical involves biotechnology, but this connection is often ignored or rejected. That causes problems in communication and public perception. This article examines biopharmaceutical terminology and ramifications for the industry. There are four major views of biopharmaceutical—the intersection of biotechnology and pharmaceuticals—based on different views of biotechnology. (See Models of Biopharmaceutical Terminology.) Part I examines why terminology is important and discusses technically grounded definitions based on underlying (bio)technologies and historical and regulatory definitions, including the broad biotechnology view of biopharmaceutical as pharmaceuticals manufactured using biotechnology and the new biotechnology view restricted to genetic engineering. Part 2 will look critically at how terms are being redefined by industry sectors and the press (trade and popular) based on business models (company type). In that view, biopharmaceutical is no longer linked to biotechnology, and small molecule drugs and companies with no biotechnology involvement are included. That discussion will include the biotechnology business view, which considers biotechnology to include any small, R&D-intensive life-science company, and the newer pharmaceutical business view that simply redefines pharmaceutical, including all drugs and big pharma, as biotechnology and biopharmaceutical.