Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
J Ocul Pharmacol Ther. 2021 Apr;37(3):157-161. doi: 10.1089/jop.2020.0041. Epub 2020 Dec 17.
New, brand-name, ophthalmology drug products are developed, investigated, and submitted for marketing approval through premarket interactions with the Food and Drug Administration (FDA). These drug applications for novel drugs are reviewed by FDA for safety and effectiveness before being allowed on the market. Many brand-name drugs are allowed a period of marketing exclusivity and/or have patent protections that can delay generic competition. When these exclusivity periods or patents expire or are challenged (in the case of patents), generic competitors may then market equivalent products, as allowed by U.S. law (eg, Drug Price Competition and Patent Term Restoration Act, often referred to as "the Hatch-Waxman Act"). To be approved as a therapeutic equivalent, a generic product must demonstrate that it is both pharmaceutically equivalent and bioequivalent to the brand-name drug product, which can involve innovative analytical methods and study designs. To facilitate generic drug assessment and approval, the FDA has negotiated the Generic Drug User Fee Amendments (GDUFA) program that funds a rigorous generic drug development program that includes pre-Abbreviated New Drug Application (pre-ANDA) correspondence and meetings, targeted bioequivalence research, and publication of product-specific guidances (PSGs) to support generic drug research and development for manufacturers interested in developing generic drugs for the U.S. market. FDA's regulatory practices include the monitoring of quality and postapproval adverse events of all marketed products, including those for use in and around the eyes.
新的、品牌的眼科药物产品是通过与食品和药物管理局（FDA）的上市前互动开发、研究和提交营销批准的。这些新药申请由 FDA 审查安全性和有效性，然后才允许上市。许多品牌药物都有一段时间的市场独占期和/或专利保护，可以延迟仿制药的竞争。当这些独占期或专利到期或受到挑战（在专利的情况下）时，仿制药竞争对手可以根据美国法律（例如，药品价格竞争和专利期限恢复法案，通常称为“ Hatch-Waxman 法案”）销售等效产品。要获得治疗等效性的批准，仿制药产品必须证明它在药物等效性和生物等效性方面与品牌药物产品相同，这可能涉及创新的分析方法和研究设计。为了促进仿制药的评估和批准，FDA 已经协商了通用药物用户收费修正案（GDUFA）计划，该计划为严格的通用药物开发计划提供资金，其中包括预简略新药申请（pre-ANDA）通信和会议、有针对性的生物等效性研究以及发布特定产品指南（PSGs），以支持有兴趣为美国市场开发仿制药的制造商的仿制药研究和开发。FDA 的监管实践包括监测所有上市产品的质量和批准后的不良事件，包括用于眼部和眼部周围的产品。
