Glaucoma and generics in Europe

• Authors: Anton Hommer

Title variants

PL

Jaskra i leki generyczne w Europie

• Languages of publication: EN

Abstracts

EN

Original drugs and generic drugs used in glaucoma differ from each other. This can lead to worse drug tolerability and, as a result, to worse patients’ compliance. Therefore, an essential issue is, besides the drug’s efficacy, its optimal tolerability for the patient. The potential differences in viscosity, pH, drop size, and surface tension has a potential strong influence on the complex delivery mechanism of the active molecule to the receptors in the eye and its clinical relevant efficacy. These differences, in addition to different appearance and handling of a “new” bottle, may pose problems with patients’ compliance after using a new preparation.

PL

Oryginalne leki i leki generyczne stosowane w jaskrze różnią się od siebie. Może to prowadzić do gorszej tolerancji na leki i w rezultacie do pogorszenia przestrzegania zaleceń przez pacjentów. Dlatego istotną kwestią jest, oprócz skuteczności leku, jego optymalna tolerancja ze strony pacjenta. Ewentualne różnice w lepkości, pH, wielkości kropli i napięciu powierzchniowym mogą mieć istotny wpływ na dostarczanie aktywnej cząsteczki do receptorów w oku i jej klinicznie istotną skuteczność. Różnice te, poza różnym wyglądem i obsługą „nowej” butelki, mogą powodować problemy z przestrzeganiem zaleceń przez pacjentów w przypadku zastosowania nowego preparatu.

Keywords

EN

benzalkonium chloride; bioavailability; compliance; eye drops; timolol

Discipline

• MEDICINE: MEDICINE

• Publisher: Medical Education
• Journal: OphthaTherapy
• Year: 2019
• Volume: 6
• Issue: 1
• Pages: 31-36

Contributors

author

Anton Hommer

• Private Office, Vienna, Austria

References

• 1. Boimer C, Birt CM. Preservative exposure and surgical outcomes in glaucoma patients: The PESO study. J Glaucoma 2013; 22(9): 730- -735. DOI: 10.1097/IJG.0b013e31825af67d.
• 2. Center for Drug Evaluation and Research. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations. U.S. Department of Health and Human Services Food and Drug Administration 2003.
• 3. Committee for Medicinal Products for Human Use. Guideline on the Investigation of Bioequivalence. European Medicines Agency 2010 [online: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003388.pdf].
• 4. Holló G, Hommer A. Delivery of Glaucoma Care Committee of the European Glaucoma Society. The status of glaucoma diagnostics and care in Europe in 2015: a European survey. Eur J Ophthalmol 2016; 26(3): 216-220. DOI: 10.5301/ejo.5000699.
• 5. Kahook M, Fechtner RD, Katz LJ, et al. A comparison of active ingredients and preservatives between brand name and generic topical glaucoma medications using liquid chromatography-tandem mass spectrometry. Curr Eye Res 2012; 37(2): 101-108. DOI: 10.3109/02713683.2011.631722.
• 6. Leitritz MA, Lipp HP, Voykov B, et al. Original preparations versus generics – latanoprost: how similar is different? Ophthalmologe 2015; 112(2): 127-139. DOI: 10.1007/s00347-014-3097.
• 7. Mammo ZN, Flanagan JG, James DF, et al. Generic versus brand-name North American topical glaucoma drops. Can J Ophthalmol 2012; 47(1): 55-61. DOI: 10.1016/j.jcjo.2011.12.004.
• 8. OECD/EU. Health at a Glance: Europe 2014. OECD Publishing, Paris 2014. https://doi.org/10.1787/health_glance_eur-2014-en.
• 9. Rossetti L, Digiuni M, Giovanni M, et al. Blindness and Glaucoma: A Multicenter Data Review from 7 Academic Eye Clinics. PLoS One 2015; 10(8): e0136632 [online: https://doi.org/10.1371/journal.pone.0136632].
• 10. Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol 1996; 80: 389-393.
• 11. [online: https://www.eugs.org].

• Document Type: article