FDA终于出台期待已久的生物仿制药提案

FDA终于出台期待已久的生物仿制药提案发布日期：2014-05-16  来源：fiercebiotech  
【新药汇www.xinyaohui.com讯】 多年来，FDA一直着手于调控重磅生物仿制药计划，本周该机构出台了关于“如何定义准生物仿制药”条款。

                               
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在一项非约束性的指南草案中，FDA列出了在评审治疗药物与替代的已批准生物药物之间可能重复的四层条款。在最好的情况下，生物仿制药开发商将只需要在动物或人身上进行研究以证明他们的药物与其参照药疗效相似，而那些不相似的，如果其生产工艺未发生变化将不会进一步考虑。
FDA正在就该政策征求意见，希望获得行业的反馈，药物开发商8月12日前可以参与到该提案中来。为解决如何批准生物仿制药，FDA已有长达一年的努力，其中，定义生物相似性是众多未解决的问题之一，这也是欧洲自2006年以来一直在做的事情。FDA尚未确定生物仿制药的命名条款，届时生物仿制药能否与其参比药物互换使用也仍未可知。
目前，制药行业对FDA最近宣布的公告疑问重重，该公告解释了FDA将如何要求制药商提交生物仿制候选药物与其参比药物的对比分析数据。根据这些分析数据发现的差异，FDA将把每个提交的治疗药物分入以下四类：

• 高度的、指纹般相似，基于综合、多参数方法，提交申请的药物应几乎等同于其参比药物。这类药物仅需要“有针对性及选择性”地进行进一步的研究，以证实其相似性。
• 高度相似，这种相似也符合相似性的法定标准，但达不到上面提到的黄金标准。
• 相似，这适用于其分析不确定的药物，需要进一步的数据或研究，以观察生产工艺或配方的改变是否可能有助于证明其相似性。
• 不相似，该草案最明了的条款，适用于不符合其参比药物标准的药物。
  

尽管新政策出台，预测的数十亿美元生物仿制药市场仍然不会变。生物仿制药最终在美国上市，被认为是威胁重磅生物药物的底线，如安进和雅培生命，届时那些广泛使用的药物，其成本将被削去一半。
但制药业并不会低头认命。在国会授权FDA弄清楚生物仿制药审批途径以来的四年内，许多专利药制造商已开始开始投资于自己的生物仿制药运作，包括安进、默沙东和百健艾迪。
FDA breaks silence on biosimilars with long-awaited proposal
For years, the FDA has been unveiling its plan for regulating knockoffs of blockbuster biologics in fits and starts, this week outlining just how it wants to define biosimilarity for would-be copycat drugs.
In a nonbinding draft guidance, the agency spelled out four tiers of possible similarity between an under-review treatment and the approved biologic it hopes to replace. In the best-case scenario, biosimilar developers would need only targeted animal or human studies to prove their drugs match their references, while those deemed not similar would not be further considered without changes to their manufacturing processes.

The FDA is floating its recommendations in hopes of drawing industry feedback, giving drug developers until Aug. 12 to weigh in on the proposal. Defining biosimilarity is among many outstanding questions in the FDA's years-long effort to figure out how it will approve copies of biologic medicines, something Europe has been doing since 2006. The agency is also yet to come down on naming regulations for biosimilars and on when a knockoff can be used interchangeably with its reference drug.
For now, the industry has plenty to chew over with the FDA's latest announcement, which explains how the agency will require drugmakers to submit analytical data comparing biosimilar candidates to their forebears. Depending on what differences those analyses find, the FDA will file each submitted treatment into one of four categories:
Highly similar with fingerprint-like similarity, in which a submission is deemed nearly identical to its reference product, "based on integrated, multi-parameter approaches," according to the FDA. Such drugs would need only "targeted and selective" further study to demonstrate their biosimilarity.
Highly similar, which also meets the statutory standard for similarity but falls short of the above-mentioned gold standard.
Similar, a label that applies to drugs whose analyses were inconclusive, demanding further data or studies to figure out whether changes in manufacturing or formulation might help demonstrate similarity.
Not similar, the draft's most self-explanatory tier, applies to products that don't measure up to their references.
Meanwhile, the long-forecast multibillion-dollar market for biosimilars remains on hold as the FDA metes out its rules. The eventual stateside debut of biosimilars, considered a threat to the bottom lines of biologic heavyweights like Amgen ($AMGN) and AbbVie ($ABBV), is expected to slash the cost of some the most widely used drugs by nearly half.
But the industry is hardly standing pat. In the four years since Congress authorized the agency to suss out an approval pathway for biologic copies, many makers of proprietary drugs have started investing in their own biosimilar operations, including Amgen, Merck ($MRK) and Biogen Idec ($BIIB).