Imitation and innovation new biologics, biosimilars and biobetters

ABSTRACT Biopharmaceutical drugs are the future of the pharmaceutical industry. The United States is the world leader in the development of new biopharmaceutical products. These original new drugs, numbering close to 200, are now losing patent protection and imitators from several countries are entering the markets of comparable drugs, called biosimilars. Some companies are improving the original product, and these drugs are called biobetters. Even among the producers of biosimilars one finds different strategies, and these are linked to different government regulations concerning the approval of these products. Some biosimilar companies are aiming at developed-country markets (North America, the European Union and Japan), while other producers are targeting emerging, less-regulated markets. This introduction will present the dynamic picture of an industry in transition. The paper has a double aim: discuss the fuzzy frontier between imitation and innovation, and track the new contours of the pharmaceutical industry.

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