2014财年和2015财年FDA首仿批准量
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2014财年和2015财年FDA首仿批准量
笔记 2016-05-19 Lachman CONSULTANTS 2013财年,仿制药办公室(OGD)报告批准了108个首仿产品。这一信息来自OGD的仿制药批准报告(url)2013年首仿清单(url)。因为自我们观察首仿批准和OGD现在已经开始加快对首仿产品的审评(在某些情况下)已有一段时间,我想我们应该再来看看2014财年和2015财年以及2016财年前7个月的数字。 下表列出了各时期FDA报告的首仿药批准。
* - 2016财年截至2016年4月 虽然这些数字很有意思,但我不能肯定除了FDA自己所说的之外我们能说多少。因为2015年仅有71件首次获批,我们应该得出OGD放缓的结论吗?一点都不能。显然有一些因素在OGD的控制之外,例如专利和专营权保护,包括5年NCE专营权、3年Hatch-Waxman专营权和180天仿制药专营权,更不用说儿科专营权延长和专利延期。此外,首次获得仿制药批准资格的产品数量的变更和大量其它问题,像申请质量、产品或API的复杂性,也影响OGD将首仿药推向市场的能力。然而,这张表显示了OGD专注于尽可能快的将首仿药推向市场。 未来,如果ANDA批准流程具有足够快的速度,GDUFA目标日期达到10个月,我们也许能够更多的对比ANDA接收量和首仿药批准的百分比。但,即使这样,试图仅根据这两个指标做出假设很有可能会被证明是目光短浅的,因为无法从有效的数据中搜集完整的故事。希望首仿药获批数量与批准限制一致,并反映OGD的努力以保证,如果一件ANDA可以作为首仿批准,它会在可以被合法批准的首日获得批准。 Lachman CONSULTANTS - Bob Pollock先生 First-Time Generic Approvals in FY 2014 and 2015 In December 2014, we did a story on First-Time generic approvals for FY 2013 (here). In that post we noted that, for FY 2013, the Office of Generic Drugs (OGD) reported approving 108 first time generic products. This information was taken from OGD's Generic Approval reports (here) and navigating to 2013's First-Time list (here). Because it has been a while since we looked at First-Time generic approvals, and since OGD has now begun to expedite the review of First-Time generic products (in certain circumstances), we thought we would take another look at the numbers for FY 2014 and 2015 and the first 7 months of FY 2016. The table below outlines FDA’s reports of first generic approvals for the respective time periods.
*- FY 2016 through April 2016 While these numbers are interesting, I am not certain how much we can say about them other than they speak for themselves. Should we conclude that, because in 2015 only 71 first time approvals were made, OGD had a slow down? No, not at all. There are obviously a number of factors outside of OGD's control, such as patent and exclusivity protection, including 5-year NCE exclusivity, 3-year Hatch-Waxman exclusivity and 180-day generic exclusivity, not to mention pediatric exclusivity extensions and patent delays. In addition, the changing number of products that may be first time eligible for generic approval and a host of other issues like application quality, the complexity of the product or the API also impact OGD's ability to get First-Time generics to market. However, this chart does demonstrate that OGD does focus on brining First-Time generic drugs to market as fast as they can. In the future, if the ANDA approval process picks up enough speed and as the GDUFA goal dates hit 10 months (as they will in FY 2017), we may be able to make more of a comparison of the number of ANDA receipts and vs the % of First-Time generic approvals. But, even then, trying to make assumptions based on just those two metrics may prove to be shortsighted as the full story cannot be gleaned from that limited data. The hope would be that the numbers of first generic approvals will be consistent with the limitations for approval and reflect an effort by OGD to assure that, if an ANDA can be approved as a first generic, it is approved at the first date that it can be legally approved. |