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6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 FDA What are the Generic Drug Requirements? • Same active ingredient(s) • Same route of administration • Same dosage form • Same strength • Same conditions of use • Compared to reference listed drug (RLD) - (brand name product) Center for Drug Evaluation and Research FDA FDA Requirements for Generic Ophthalmics According to Dr Wiley Chambers Acting Director of the Division of Anti-Infective and Ophthalmology Products at the FDA, there are two potential paths to market for generic ophthalmic solutions approved after 1992. Center for Drug Evaluation and Research Wayne Weart, Pharm D Cost Effective Rx
6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 FDA FDA Requirements for Generic Ophthalmics The first path involves a waiver of clinical trials if the generic ophthalmic solution has the same active and inactive ingredients in the same concentrations as the original. “If it does not have the same active and inactive ingredients in the same concentrations, then it would have to demonstrate bioequivalence in a clinical study,” says Dr. Chambers. “For ophthalmic drug products where the innovator (the original proprietary drug) was approved prior to 1992, there are cases where the inactive ingredients are not the same as the innovator. Center for Drug Evaluation and Research FDA FDA Requirements for Generic Ophthalmics According to IMS Health, latanoprost- Xalatan had U.S. sales of about $711 million in 2010. Cost is the most obvious allure generics have, especially for pharmacy benefit managers. In fact, many pharmacy benefit formularies have dropped Xalatan this year in favor of the generic solution. Center for Drug Evaluation and Research Wayne Weart, Pharm D Cost Effective Rx
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6 th Annual Primary Care Spring Conference Thursday, April 12, 2012<br />
FDA<br />
FDA Requirements for Generic<br />
Ophthalmics<br />
The first path involves a waiver of clinical trials if the<br />
generic ophthalmic solution has the same active and<br />
inactive ingredients in the same concentrations as the<br />
original. “If it does not have the same active and<br />
inactive ingredients in the same concentrations, then it<br />
would have to demonstrate bioequivalence in a clinical<br />
study,” says Dr. Chambers. “For ophthalmic drug<br />
products where the innovator (the original proprietary<br />
drug) was approved prior to 1992, there are cases<br />
where the inactive ingredients are not the same as the<br />
innovator.<br />
Center for Drug Evaluation and Research<br />
FDA<br />
FDA Requirements for Generic<br />
Ophthalmics<br />
According to IMS Health, latanoprost-<br />
Xalatan had U.S. sales of about $711<br />
million in 2010. Cost is the most obvious<br />
allure generics have, especially for<br />
pharmacy benefit managers. In fact, many<br />
pharmacy benefit formularies have<br />
dropped Xalatan this year in favor of the<br />
generic solution.<br />
Center for Drug Evaluation and Research<br />
Wayne Weart, Pharm D<br />
Cost Effective Rx
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