2014-04-20 识林

2014年，进退维谷之间，仿制药公司面临着很多迫在眉睫的两难选择，其中一些并没有简单的答案。但希望企业宜早不宜迟考虑自己的选择。其中两个问题涉及到最为重要的问题：“究竟应该何时提交ANDA？”任何仿制药公司都知道这个问题的答案绝非易事，依赖于很多因素，例如，生物研究的成功、完成稳定性实验、设施检查准备妥当，以及首次提交的机会，这里仅列举一些。当然，这类实践科学或监管期限进一步因“越快越好”商业目标导向而变得更加复杂。

2014年的两个重要的里程碑将显著影响本年度ANDA提交和审评时间，并带来又一波仿制药项目规划组合。新的OGD稳定性指南于2014年6月20日生效。指南勾勒出的影响ANDA提交的大变化是在提交申请时包含3批药品申报批的6个月加速和室温稳定性数据要求。从FDA的视角来说，新要求的根据是可以理解的（与ICH更加一致，数据越多越好），还是回到现实— 增加3个月的稳定性数据？以及额外2个批次？精打细算的帐房先生肯定会告诉研发和注册部门，在产品获批之前需要花更多的钱。……因此要力推在6月20日之前提交。请务必要记住，对于那些试图赶上现行1批和3个月稳定性要求者，您的申请必须在其它方面按立卷要求完成，因为，如果您的ANDA被拒绝立卷，并且如果您在6月20日或者之后重新提交ANDA，您必须在重新提交时符合新的稳定性要求。

别急，还有其它2014年的里程碑需要考虑。2014年10月1日迎来GDUFA的第3年；这是终于踢开GDUFA目标函所列审评指标大门的一年。2015财年对于原始ANDA的GDUFA目标，必须对提交的60%ANDA申请在15个月（第5个GDUFA年（2017财年）进展至10个月内90%）内采取行动（审评，但不一定批准）。提交申请并知道何时会被挑入审评，或至少60%的时候你的行动日期将是何时？好极了！

那么企业该如何做？力推在2014年6月之前提交一批稳定性批次的ANDA，并看着它在没有审评目标日期的被遗弃的申请队列中日渐憔悴（可能需要几年的时间）？还是咬紧牙关，为额外的实验和2批展示批花钱，在10月1日或之后提交ANDA，知道申请在2014财年至少60%的时候将处于GDUFA目标审评指标下？将更多的金钱花在等待批准而不是用在遵守新的要求？谁又能知道？谁又做最后的决定？是时候开始捣弄这些数字了，赶快。

Lachman CONSULTANTS - Diana Sloane女士和Bob Pollock先生 2014-04-09
编译：识林-椒 2014-04-20

Big Decisions Loom in 2014 for Generic Applicants
Written by Diana Sloane and Bob Pollock • April 09, 2014

Betwixt and between, there are a number of dilemmas looming over generic drug firms in 2014 – some with no easy answers, but hopefully firms are considering their choices sooner rather than later. Two of these issues relate to the all-important question “Exactly when should the ANDA be submitted?”. Any generic drug firm knows that that answer is never easy and is dependent on many factors, such as biostudy success, completion of stability testing, facilities being ready for inspection and first-to-file opportunities, just to name a few. And of course, such practical scientific or regulatory deadlines are further complicated by the directed business goal of “the sooner the better”.

Two major milestones in 2014 will significantly affect ANDA submission and review times in this year and brings yet another wrinkle to the generic drug project planning mix. Effective June 20, 2014, the new OGD Stability Guidance applies. The big change outlined in the guidance which impacts ANDA submission is the requirement for inclusion of 6 months accelerated and room temperature stability data on 3 drug product exhibit batches at the time of filing of the application. While the basis for the new requirement is understandable from FDA’s perspective (aligns more with ICH, the more data the better), still, reality sets in - 3 additional months of stability data? And 2 more batches? You can be guaranteed the bean counters are telling R&D and Regulatory to get that product in before more money has to be spent. …so the push to get the submission in before June 20th is on. Be certain to remember that, for those trying to beat the clock with the current 1 batch and 3-month stability requirement, your application must be otherwise complete for filing purposes, because, if your ANDA is refused for filing, and if you resubmit your ANDA on or after June 20, you must meet the new stability requirements in the resubmission.

But wait, there is also that other 2014 milestone to think about. October 1, 2014 brings the start of GDUFA year 3; the year when the review metrics outlined in the GDUFA Goals letter finally kicks in. The FY 2015 GDUFA goal for original ANDAs is that 60% of those ANDAs submitted must be acted upon (reviewed, but not necessarily approved) in 15 months (progressing to 90% in 10 months by GDUFA year 5 (FY 2017)). Submitting an application and knowing when it will be picked up for review or when your action date will be at least 60% of the time? Sweet!

So what is a firm to do? Push to submit a one stability batch ANDA before June 2014 and have it languish (possibly for years) in the forlorn queue of applications with no review goal dates? Or bite the bullet, spend the money for additional testing and 2 more exhibit batches and submit the ANDA after on or after October 1 with the knowledge it will be subject to GDUFA goal review metrics at least 60% of the time in FY2014? Will more money be lost waiting for an approval than spent complying with new requirements? Who’s to know and who makes the final call? Time to start crunching those numbers, and quickly.