美国生物仿制药行业遭受立法打击(原创翻译 非首发)

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美国仿制药行业说客最近受到了不小的打击，国会的一个委员会通过一项保护性议案，给予品牌生物制剂制造者长达12年的排他性保护期。由于美国市场是新兴生物仿制药行业能否成功的关键，这项立法可能会给所有胸怀大志的仿制药业者泼上一盆凉水。
能源与贸易委员会是通过这项法案的三个国会委员会中的最后一个，参议院中的这一委员会立志于审查美国健康照护系统。这项“美国可负担的健康选择法案” (HR3200)本身仅以微弱优势获得通过(31:28)，但其中生物仿制药修正部分却获得大多数的支持(41:11)。
参议员Anna G Eshoo、Jay Inslee和Joe Barton等共同提议了这项修正案，在品牌生物制剂上市后的12年内，排除任何生物仿制药获得市场准入。对于儿科适应症，此期限还附加延长6个月。这些条款与7月13日参议院健康教育劳工养老金（HELP）委员会所通过的一项法案类似。
出于消费者团体、仿制药公司、最重要的能量通天的高级游说团体——美国退休者协会的争取，这些法案也兼顾了各方利益，如提供了缩短排他性保护期的可能。奥巴马总统也公开表明，支持为其7年的品牌生物制剂的排他保护。联邦贸易委员会最近发布的一份报告也明确指出，12-14年的保护期是没有必要的。因此，缩短市场排他期仍然是可能的。
给予品牌生物制剂长达12年的排他性保护期，健康照护的支付者将是最终的输家，他们将不得不为昂贵的品牌药买单更久。然而，如Datamonitor所预期的，生物仿制药需要从在美国市场中汲取发展的动力，这些法案对其仍然是致命的打击。

http://www.datamonitor.com/store ... 9-A181-0F2FF1D7DCC4

In something of a blow to the pro-generic lobby in the US, a House committee has voted through a provision which would allow branded biologics manufacturers a guaranteed exclusivity period of 12 years. With the US market likely to be pivotal in the success of the still emerging biosimilars industry, the future of this legislation will have repercussions for all aspiring biosimilars players.

Energy and Commerce was the last of the three House committees to pass legislation, which is to be amalgamated and combined with that from the Senate in a bid to overhaul the US healthcare system, a key item on President Obama's agenda. Although the bill itself, 'America's Affordable Health Choices Act' (HR3200), was passed with a narrow margin (31 to 28), the biosimilars amendment carried a much greater majority (41 to 11).

The amendment, sponsored by senators Anna G Eshoo, Jay Inslee and Joe Barton, would preclude any biosimilar from gaining marketing approval within the first 12 years of branded biologic launch, with an additional six months available for those drugs with pediatric indications. These terms are similar to those attached to a bill passed by the Senate's Health, Education, Labor, and Pensions (HELP) committee, on July 13.

The bills have yet to be amalgamated, offering the opportunity still for the exclusivity period to be shortened, an outcome which consumer groups, generics companies, and most prominently the powerful seniors' lobby group the American Association for Retired Persons, will be strenuously campaigning for. President Obama has also gone on record in favor of a seven year exclusivity period for branded biologics, and a recent Federal Trade Commission report was unequivocal that 12-14 years is unnecessary. A shorter period of market exclusivity therefore remains a distinct possibility.

Should the final approval pathway offer branded biologic makers 12 years of exclusivity, the healthcare payer will be the ultimate loser, having to spend more on expensive branded drugs for longer. However, given that Datamonitor expects much of the growth in the biosimilars sector to be fuelled by the US market, this emerging industry will also be dealt a potentially lethal blow.