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Okulistyczne leki oryginalne vs generyczne stosowane w farmakoterapii jaskry
Brand Name vs Generic Medications for Glaucoma Treatment
Marta Bramorska1, Reza Fakhari1, Iwona Grabska-Liberek1,2
1 Klinika Okulistyki SPSK im. prof. W. Orłowskiego w Warszawie CMKP
Kierownik: dr hab. n. med. Iwona Grabska-Liberek, prof. nadzw. UHT
2 Uniwersytet Technologiczno-Humanistyczny w Radomiu
Summary: Generic drugs are in the majority on the world market. However, in ophthalmology brand name drugs are still in favour. Ophthalmic generic medications are mostly used for glaucoma treatment. Glaucoma is the leading cause of irreversible blindness in the world. Method for treating glaucomatous optic neuropathy is to lower intraocular pressure through topical medications. There are several classes of topical drugs out of which prostaglandin analogues are considered to be the most effective and have limited side effects. Latanoprost, also known by the brand name of Xalatan, manufactured by Pfizer was the first prostaglandin analogue which rapidly became the most commonly prescribed glaucoma eye drop in United States and Europe. A new developed drug is covered under patent protection, which means that only the pharmaceutical company that holds the patent is allowed to manufacture, market the drug and eventually make profit from it. Once the patent has expired, the drug can be manufactured and sold by other companies. Since Xalatan has been no more under patent protection, over a dozen generic versions of latanoprost is now widely available. According to guidelines in most countries, generic drug has to be identical to the branded drug in terms of efficacy, safety, usage, route of drug administration, pharmacokinetics and pharmacodynamics. It contains the same active ingredients as its corresponding brand name drug, but the inactive ingredients in generic formulations, e.g. the solution in which the drug is dissolved and its preservative, may be different. The generic drugs do not undergo the same rigorous testing that is undertaken when the original patented product is released. For this reason most eye doctors are concerned about using generic medications because the effectiveness, tolerability, and side-effect profiles are unknown. With systemic drugs bioequivalence studies are performed using blood samples to determine whether the plasma concentration within certain limits equals the branded drug. With topical eye drops such studies obviously cannot be performed. Several clinical studies were carried out to compare generic glaucoma medications with their brand-name predecessors. They revealed inequality in reducing intraocular pressure, less stability after exposure to high temperature and more ocular side-effect after treatment with generic equivalent drugs . Doctors must closely monitor patients after they switch to ensure the safety and effectiveness of the generic medication.
Słowa kluczowe: leki oryginalne, leki generyczne, farmakoterapia jaskry, latanoprost, ochrona patentowa.
Keywords: brand name drugs, generic drugs, glaucoma treatment, latanoprost, patent protection.