Akademik Veri Yönetim Sistemi
Journal of Literature Pharmacy Sciences, cilt.10, sa.2, ss.166-175, 2021 (Hakemli Dergi)
The generic drug contains the same active substance as
the referenced original drug, in the same dose, in the same or similar
pharmaceutical form and can be produced after the patent protection
period of the original drug expires. With "The Drug Price Competition and Patent Term Restoration Act", informally known as the
“Hatch-Waxman Act” in 1984, the requirement for pre-clinical and
clinical phase studies was abolished in the approval process of generics. In this context, replacement of the former process with the "abbreviated new drug application" has streamlined the widespread use
of generics. Generic drug is deemed as therapeutically equivalent to
reference product by demonstrating bioequivalence through bioavailability/bioequivalence studies conducted with a limited number of
healthy volunteers. Therefore, generic drugs introduced to the market
with lower costs are generally cheaper than reference drugs. In this
way, generic drugs make a critical contribution to reducing drug expenditures without conceding healthcare quality. In fact, especially
in developed countries, it was aimed to off-load the pressure caused
by drug costs on the health budget via increasing the use of generic
drugs, and special policies have been implemented. Apart from administrative policies, many factors including consumers’, pharmacists’, and physicians’ perceptions and behaviors about generics,
diagnosis and drug-related characteristics, etc. can impact in spreading the use of generic drugs. In this review, it was aimed to provide
fundamental information about generic drugs and present the developments in the world and in Turkey for these drugs which are becoming more widespread.