TY - JOUR
T1 - Generic medications in ophthalmology
AU - Zore, Matt
AU - Harris, Alon
AU - Tobe, Leslie Abrams
AU - Siesky, Brent
AU - Januleviciene, Ingrida
AU - Behzadi, Jennifer
AU - Amireskandari, Annahita
AU - Egan, Patrick
AU - Garff, Kevin
AU - Wirostko, Barbara
PY - 2013/3
Y1 - 2013/3
N2 - The purpose of this review is to discuss the process of genericisation of medications in the US and Europe with a focus on ophthalmic drugs. Regulatory guidelines of the US Food and Drug Administration and the European Medicines Agency will be discussed, and the advantages and concerns of genericisation will be explored. We will look at various studies concerning the safety and efficacy of generic drugs compared to their branded counterparts. In particular, the challenges of assuring bioequivalence and therapeutic equivalence in topical ophthalmic drugs will be examined.
AB - The purpose of this review is to discuss the process of genericisation of medications in the US and Europe with a focus on ophthalmic drugs. Regulatory guidelines of the US Food and Drug Administration and the European Medicines Agency will be discussed, and the advantages and concerns of genericisation will be explored. We will look at various studies concerning the safety and efficacy of generic drugs compared to their branded counterparts. In particular, the challenges of assuring bioequivalence and therapeutic equivalence in topical ophthalmic drugs will be examined.
UR - http://www.scopus.com/inward/record.url?scp=84874662695&partnerID=8YFLogxK
U2 - 10.1136/bjophthalmol-2012-302245
DO - 10.1136/bjophthalmol-2012-302245
M3 - Review article
C2 - 23143788
AN - SCOPUS:84874662695
SN - 0007-1161
VL - 97
SP - 253
EP - 257
JO - British Journal of Ophthalmology
JF - British Journal of Ophthalmology
IS - 3
ER -