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2015-09-02 Lachman CONSULTANTS

仿制药办公室（OGD）8月完全批准58件ANDA，打破了之前GDUFA实施后57件（6月批准量）完全批准的记录。本月同时发布6件暂时批准，总共64件批准行动。这对OGD来说是个好消息，企业针对OGD批准效率的持续审查已持续一段时间。有趣的是，本月仅收到32件新递交的ANDA，本财年倒数第3低的接收月份，OGD第二次批准量超越接收量。距本财年结束仅余1个月，采用直线预测，预计OGD将批准470件ANDA（新的GDUFA批准记录），接收487件新的ANDA（GDUFA实施以来最低量）。批准和接收之间的微小差距让人有点意外，尤其是FDA对于下一年度提交量的预测是800件，而过去一年的提交量为1000件左右。

9月份的接收量会由于GDUFA ANDA申请费的上升而出现较大增长吗？我猜测不太可能，因为在我看来，GDUFA目标从第3队列年（15个月内60%审评）到第4年队列（15个月内75%的审评）变化，没有足够大的动力赶在财年更替前递交申请。然而，第5队列年的目标是10个月内90%的审评，这可能足以刺激企业将下一财年末准备提交的申请延迟至新财年递交。OGD宣称今年将达到或超越GDUFA目标，但我只是没有看到在本财年末大量涌入的ANDA。另一个可能引发在第5队列年到来之前递交的重要因素是下一财年ANDA申请费的增长。如果2016财年递交率持续下降，或停留在今年的水平，2017财年ANDA申请费可能再次大幅度上涨（2016财年ANDA费上涨29.5%）。企业是否对任何费用成本变化的敏感度超过GDUFA第5队列年目标ANDA审评时间的改善，还有待观察。

无论如何，对于明年已有太多的猜测，众所周知的境况已经开始好转，FDA建造的ANDA审评机器将挂上高速档位。企业是会满意？还是会期待更多？

Lachman CONSULTANTS - Bob Pollock先生 2015-09-02
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August 2015 ANDA Approvals Break a GDUFA Record, But Receipts Flounder
By Bob Pollock | September 2, 2015

The Office of Generic Drugs (OGD) broke its old post-GDUFA approvals record of 57 by one, issuing 58 full approvals in August 2015. OGD issued 6 Tentative Approvals in the month for a total of 64 approval actions on ANDAs for the month. This is good news for OGD in a time of continued scrutiny by industry relative to its approval productivity. Quite interestingly, the number of new ANDA receipts for the month was only 32, the third lowest for this fiscal year, and gives OGD only its second month (and second month in a row) where approvals exceeded receipts this fiscal year. Using straight line projections, and with one month to go before the close of the FY, it is estimated that OGD will approve about 470 ANDAs (a new GDUFA record) and receive 487 new applications (the lowest number by far under GDUFA). This small gap between approvals and receipts is a bit unexpected, especially since the FDA projection for submissions next year is 800 and this past year was in the neighborhood of 1000.

Will the September receipts show a big increase due to the rising GDUFA ANDA fees? I am guessing not likely as the change in the GDUFA goals from cohort year 3 (60% review within 15 months) to cohort year 4 (75% review in 15 months) is not, in my opinion, that big of a motivator to getting applications in ahead of the FY change. However, the cohort year 5 goal of 90% review in 10 months may be enough of an incentive for firms to wait to submit applications towards the end of next FY if they are close to the new FY. With OGD professing that it will meet or exceed GDUFA goals this year, I just don’t see the rush for slipping in ANDAs prior to the end of this FY. Another motivator next year for getting applications in prior to the beginning of cohort year 5 may be a substantial potential for an increase in the ANDA fee next FY. If there is a continued decrease in submission rates in FY 2016, or they stay at this year's level, the ANDA fee may see another substantial increase in FY 2017 (the ANDA fee rose 29.5% for FY 2016 applications). Whether industry will determine that any dollar cost differential will outweigh the improved timing for ANDA review under the GDUFA cohort year 5 goals remains to be seen.

Anyway, enough speculation about next year- it may be time to think that the proverbial corner has been turned and the ANDA review machine that has been under construction at the Agency may be kicking into a higher gear. Will industry be satisfied or are they expecting more?