FDA新局长的首要任务就是降药费，正大力推动Biosimilar教育活动

flydengfeng

来自：Tony Zhang 药品注册英语学习平台

FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options
FDA采取新步骤，通过教育以便更好的告知医生生物类似药是潜在节约成本的选择

Posted on October 23, 2017 by FDA Voice
2017年10月23日发表在FDA Voice

By: Scott Gottlieb, M.D., and Leah Christl, Ph.D.
注：M.D医学博士；Ph.D哲学博士


The cost of prescription drugs is an ongoing concern, however, a growing market for potentially lower-cost biological products called biosimilars can offer more competition and options for patients.
处方药成本是一个持续关注的问题，然而，日益增长的潜在低成本称为生物类似药的生物产品市场能够为患者提供更具竞争力的选择。

Biosimilars can potentially reduce costs for consumers by creating price competition for products that previously faced few market competitors. FDA wants to ensure that health care providers have the information they need when considering prescribing biosimilars when these products are available.
生物类似药可以通过为以前面临少数市场竞争对手的产品制造价格竞争来为消费者降低成本。当产品可获得时，FDA希望确保卫生保健提供商在考虑处方生物类似药时有他们需要的信息。

An FDA-approved biosimilar is highly similar to — and has no clinically meaningful differences in terms of safety, purity and potency (safety and effectiveness) from — an already FDA-approved biological product, called the “reference product.” In general, biological products are highly complex and are often used to treat patients with serious and life-threatening conditions.
一个FDA批准的生物类似药是与被称为“参比品”的已经FDA批准的生物产品高度相似的，并且它们之间在安全性、纯度、效力（安全性和有效性）方面没有临床意义上的区别。一般而言，生物制品高度复杂的，常用于治疗处于严重和威胁生命情形的病人。

FDA’s Center for Drug Evaluation and Research (CDER) has approved seven biosimilars to date.  As more biosimilars are approved by FDA, we want health care providers to understand what these drugs are, and how they can help patients. So we are taking new steps to make sure providers are properly informed about biosimilars by launching an educational campaign today.
到目前为止，FDA的药品评价与研究中心（CDER）已经批准了7个生物类似药。随着更多的生物类似药由FDA批准，我们希望健康保健提供商了解这些药物是什么，以及这些药物如何能够帮助病人。因此，我们正采取新的步骤通过现在发起一项教育活动来确保健康保健提供商正确的了解生物药。
We planned and researched extensively prior to developing the materials for this education and outreach effort. Through this process, we learned the specific areas that health care providers had questions about. These include questions about the data and information FDA reviews when it’s making decisions to approve a biosimilar.
在为这项教育和推广工作开发材料之前, 我们进行了广泛的计划和研究。经历这个过程，我们了解了健康保健提供者在特定领域存在的问题。这些问题包括，当决定批准一个生物类似药时，FDA审评的数据和信息。

Based on that feedback, FDA has developed educational materials to help health care providers gain a better understanding of these important products and the approval process they undergo. This includes fact sheets and graphics for health care professionals, as well as materials for organizations to use in disseminating this information to their interested members.
基于这些反馈，FDA已经开发了教育材料来帮助卫生保健提供者更好地理解这些重要的产品以及他们所经历的审批过程。这包括为卫生保健专业人员提供的事实表格和图形，以及用于向他们感兴趣的成员传播这些信息的组织的材料。

These resources:
这些资源：

Provide the basic definitions of terms like: biological product, reference product, biosimilar, interchangeable; and other terms to facilitate understanding of the relationship between biosimilars and their reference products;
提供术语的基本定义，如：生物制品、参比品、生物类似药、可互换；和其他促进理解生物类似药和参比品之间联系的术语；

Describe the rigorous standards any biosimilar must meet prior to approval and explain how the FDA approval pathway works for these products; and,
描述批准前任何生物类似药必须满足的严格标准，以及解释FDA批准途径如何为这些产品工作；和，

Provide easily accessible information about the data and information FDA reviews to determine biosimilarity, and how to find more resources.
提供易获得的信息，这些信息是关于FDA审评决定相似性的数据和信息和如何找到更多的资源。

The new website also highlights information about an important reference for biosimilars known as the “Purple Book”. This reference can help prescribers and patients learn which biological reference products currently have one or more approved biosimilar or interchangeable product approved by FDA.
新网站还强调了关于生物类似药的一个被称为“紫皮书”的重要参考资料。这一参考可以帮助医生和病人了解当前哪些生物参比品有一个或多个已批准的生物类似药或可互换产品。

Next, FDA plans to embark on additional research with health care professionals to learn more about the types of information prescribers need to properly communicate with their patients about biosimilars. An increase in market competition, offered by a growing complement of biosimilars, may lead to meaningfully reduced costs for both patients and our healthcare system.
下一步，FDA计划与卫生保健专业人员开展额外的研究，以了解更多关于医生需要与患者进行生物类似药的适当沟通的信息类型。越来越多的生物类似药所引起的市场竞争的加剧，可能会显著降低患者和我们的医疗保健系统的成本。

As with the significant savings that we’ve seen through the introduction of generic drugs in the United States, biosimilars could also lead to substantial savings, thereby potentially improving access and promoting better public health outcomes. Understanding the rigorous process FDA uses to evaluate biosimilars can help prescribers and patients maximize the benefits from these products.
与我们在美国引入仿制药所带来的显著节省一样，生物类似药也可能带来大量的节省，从而有可能改善获取和促进更好的公共卫生结果。了解FDA用来评估生物类似药的严格过程可以帮助医生和患者最大化这些产品带来的益处。

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration
Scott Gottlieb, M.D.,美国食品药品监督管理局（FDA）局长
Leah Christl, Ph.D., is the Associate Director for Therapeutic Biologics in the Office of New Drugs, at FDA’s Center for Drug Evaluation and Research
Leah Christl, Ph.D.,美国食品药品监督管理局（FDA）药品审评与研究中心（CDER）新药办公室（OND）治疗生物学副主任


日积月累

Associate Director 副主任
Commissioner 局长
generic drug 仿制药
biosimilar 生物类似药
basic definitions 基本定义
interchangeable 可互换
extensively 广泛的
to date 到目前为止
launch an educational campaign 发起教育活动
is highly similar to 与...高度相似
in terms of 在...方面；依据...
reduce cost 降低成本
gain a better understanding of 获得对...更好的理解
An increase in market competition 市场竞争的加剧
is an ongoing concern 是一个持续关注的问题
So we are taking new steps to make sure 所以我们正采取新措施以确保

一沙一叶

转移到中国生产？  

wwd7212

翻译的好了

zysx01234

不错

套路

额，比如可以涨工资？


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xqliu

学习一下啦，谢谢提供分享。

syhorchid

FDA首脑也换人了？

3xeye

意思是生物类药品可以降低药品费用？