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Biological Drugs and the Coming of Biosimilars
Author(s) -
Power David A,
Ford David
Publication year - 2008
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/j.2055-2335.2008.tb00820.x
Subject(s) - biosimilar , medicine , biological drugs , identification (biology) , risk analysis (engineering) , agency (philosophy) , drug , confusion , european market , pharmacology , marketing , microbiology and biotechnology , business , disease , commerce , psychology , philosophy , botany , epistemology , pathology , psychoanalysis , biology
Protein‐based therapies or ‘biological drugs' were developed using gene manipulation techniques and have been very successful in providing significant benefits in many clinical areas. They have also generated substantial profits for their innovators. Many of these drugs are now coming off patent and other manufacturers have expressed an interest in marketing similar proteins, competing on price in a manner similar to generic chemical drugs. In the case of biological drugs, however, there are significant problems in producing a drug with identical properties to the existing therapy. This problem has been acknowledged by the European Medicines Agency and they have developed a strategy to bring these ‘biosimilar' drugs to market. The entry of these biosimilars into the market is likely to produce problems, as the substitution of one biosimilar product for another is unlikely to be acceptable as they are not identical. The profusion of biosimilars for the more profitable biological drugs, such as erythropoietin, is also likely to provoke confusion in drug identification, as the World Health Organization seems unlikely to distinguish biosimilars produced by different manufacturers with distinct International Nonproprietary Names. These issues require identification by pharmacists, especially those in hospital practice, as they will be required to track and dispense these imminent different biosimilars.