Abstract
The use of generic medicines has grown considerably in recent years providing considerable cost savings. In England, generic items represented 11.7% of prescriptions for glaucoma and ocular hypertension in 2009, increasing to 55.2% of prescriptions in 2018. Generics can be brought to the market quickly and at low cost as manufacturers are not required to repeat animal or clinical research on active ingredients already approved for safety and efficacy. Although there is no regulatory requirement for studies comparing branded and generic eye drops, several randomised crossover studies have been performed comparing branded and generic prostaglandin analogues. While most have shown similar intraocular pressure lowering, studies are of short duration and have not evaluated visual field endpoints. Furthermore, differences in inactive ingredients, pH, viscosity, levels of particulate matter, and degradation over time have been reported. Other potential problems with generic eye drops include differences in bottle design affecting adherence, problems with supply, and the possibility that reduced revenue for innovator companies will lead to reduced investment in new drug development. This article reviews the potential advantages and disadvantages of generic antiglaucoma medications.
Highlights
Generic medications are defined by the World Health Organization (WHO) as pharmaceutical products intended to be interchangeable with an innovator product, manufactured without a licence from the innovator company and marketed after the expiry date of the patent or other exclusive rights [1]. ey are required to have the same active ingredient, route of administration, dosing, and be manufactured to the same quality standards as the reference medication but may have different inactive ingredients and packaging [1, 2]
Generic items accounted for only 19% of prescription drugs sold in the United States (US) in 1984, increasing to 43% in 1996, and 89% in 2017 [5]. is has resulted in significant savings for healthcare systems, with an estimated saving in the US of $1.67 trillion between 2007 and 2016 [6]. e use of generics has increased in ophthalmology, especially in the medical treatment of glaucoma
Article titles and abstracts were manually reviewed and of the 221 records screened, 178 were excluded as they were not deemed to relate to the use of generic medications in glaucoma. ough Cochrane protocols were identified proposing reviews of generic versus branded antiepileptic drug monotherapy in epilepsy (18th Sep 2015) and clozapine for schizophrenia (24th Jan 2019), no completed reviews were found and no Cochrane reviews or protocols were identified relating to generic ophthalmic medications. e full texts of the remaining 44 records were examined and one was excluded as it related to a single case report
Summary
Princess Alexandra Eye Pavilion, University of Edinburgh, Chalmers Street, Edinburgh EH3 9HA, UK. E use of generic medicines has grown considerably in recent years providing considerable cost savings. Generics can be brought to the market quickly and at low cost as manufacturers are not required to repeat animal or clinical research on active ingredients already approved for safety and efficacy. There is no regulatory requirement for studies comparing branded and generic eye drops, several randomised crossover studies have been performed comparing branded and generic prostaglandin analogues. Differences in inactive ingredients, pH, viscosity, levels of particulate matter, and degradation over time have been reported. Other potential problems with generic eye drops include differences in bottle design affecting adherence, problems with supply, and the possibility that reduced revenue for innovator companies will lead to reduced investment in new drug development. Is article reviews the potential advantages and disadvantages of generic antiglaucoma medications Other potential problems with generic eye drops include differences in bottle design affecting adherence, problems with supply, and the possibility that reduced revenue for innovator companies will lead to reduced investment in new drug development. is article reviews the potential advantages and disadvantages of generic antiglaucoma medications
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