Biosimilars Set to Further Expand the Biopharmaceutical Market

摘要

Biosimilars are continuing to change the biopharmaceutical industry. Some biosimilars and biogeneric products have already entered world markets, and the rather full development pipeline1 means many more are coming, along with many new entrants into the biopharmaceutical industry. This article reviews aspects of the biosimilars' development pipeline and some of the changes biosimilars are promoting within the biopharmaceutical industry, particularly changes in biopharmaceutical manufacturing (bioprocessing). A large number of biosimilars are in development worldwide. 'Genuine'biosimilars tend to be follow-on biologies in more developed and highly regulated countries that undergo rigorous and extensive analytical and clinical testing, including in direct comparison with their reference product, the established biopharmaceutical each biosimilar seeks to 'copy.' Biogenerics, often cited as 'biosimilars,' are a subset of biosimilars generally distributed in lesser- and non-regulated international commerce. They typically lack rigorous (and very costly) analytical and clinical testing, including comparisons with reference products; and not manufactured to GMP standards. Biosimilars are only marketable after the expiration periods of government-granted exclusivities of the reference products each emulates, whether based on patents, approvals- or orphan products-related exclusivities. In this context, the biosimilars entering world markets mark the maturing of the biopharmaceutical market.