FDA新局長的首要任務就是降藥費，正大力推動Biosimilar教育活動

FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options

FDA採取新步驟，通過教育以便更好的告知醫生生物類似葯是潛在節約成本的選擇

Posted on October 23, 2017 by FDA Voice

2017年10月23日發表在FDA Voice

By: Scott Gottlieb, M.D., and Leah Christl, Ph.D.

註：M.D醫學博士；Ph.D哲學博士

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.

處方葯成本是一個持續關注的問題，然而，日益增長的潛在低成本稱為生物類似葯的生物產品市場能夠為患者提供更具競爭力的選擇。

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.

生物類似葯可以通過為以前面臨少數市場競爭對手的產品製造價格競爭來為消費者降低成本。當產品可獲得時，FDA希望確保衛生保健提供商在考慮處方生物類似葯時有他們需要的信息。

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.

一個FDA批准的生物類似葯是與被稱為「參比品」的已經FDA批准的生物產品高度相似的，並且它們之間在安全性、純度、效力（安全性和有效性）方面沒有臨床意義上的區別。一般而言，生物製品高度複雜的，常用於治療處於嚴重和威脅生命情形的病人。

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.

到目前為止，FDA的藥品評價與研究中心（CDER）已經批准了7個生物類似葯。隨著更多的生物類似葯由FDA批准，我們希望健康保健提供商了解這些藥物是什麼，以及這些藥物如何能夠幫助病人。因此，我們正採取新的步驟通過現在發起一項教育活動來確保健康保健提供商正確的了解生物葯。

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.

在為這項教育和推廣工作開發材料之前, 我們進行了廣泛的計劃和研究。經歷這個過程，我們了解了健康保健提供者在特定領域存在的問題。這些問題包括，當決定批准一個生物類似葯時，FDA審評的數據和信息。

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.

基於這些反饋，FDA已經開發了教育材料來幫助衛生保健提供者更好地理解這些重要的產品以及他們所經歷的審批過程。這包括為衛生保健專業人員提供的事實表格和圖形，以及用於向他們感興趣的成員傳播這些信息的組織的材料。

• These resources:

這些資源：

• 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;

提供術語的基本定義，如：生物製品、參比品、生物類似葯、可互換；和其他促進理解生物類似葯和參比品之間聯繫的術語；

• 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類似葯必須滿足的嚴格標準，以及解釋FDA批准途徑如何為這些產品工作；和，

• Provide easily accessible information about the data and information FDA reviews to determine biosimilarity, and how to find more resources.

提供易獲得的信息，這些信息是關於FDA審評決定相似性的數據和信息和如何找到更多的資源。

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.

新網站還強調了關於生物類似葯的一個被稱為「紫皮書」的重要參考資料。這一參考可以幫助醫生和病人了解當前哪些生物參比品有一個或多個已批准的生物類似葯或可互換產品。

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計劃與衛生保健專業人員開展額外的研究，以了解更多關於醫生需要與患者進行生物類似葯的適當溝通的信息類型。越來越多的生物類似葯所引起的市場競爭的加劇，可能會顯著降低患者和我們的醫療保健系統的成本。

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 rigorousprocess FDA uses to evaluate biosimilars can help prescribers and patients maximize the benefits from these products.

與我們在美國引入仿製葯所帶來的顯著節省一樣，生物類似葯也可能帶來大量的節省，從而有可能改善獲取和促進更好的公共衛生結果。了解FDA用來評估生物類似葯的嚴格過程可以幫助醫生和患者最大化這些產品帶來的益處。

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration

Scott Gottlieb, M.D.,美國食品藥品監督管理局（FDA）局長

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.,美國食品藥品監督管理局（FDA）藥品審評與研究中心（CDER）新葯辦公室（OND）治療生物學副主任

日積月累

Associate Director 副主任

Commissioner 局長

generic drug 仿製葯

biosimilar 生物類似葯

basic definitions 基本定義

interchangeable 可互換

extensively 廣泛的

to date 到目前為止

launch an educational campaign 發起教育活動

is highly similar to 與...高度相似

in terms of 在...方面；依據...

reduce cost 降低成本

gain a better understanding of 獲得對...更好的理解

An increase in market competition 市場競爭的加劇

is an ongoing concern 是一個持續關注的問題

So we are taking new steps to make sure 所以我們正採取新措施以確保