What are generic drugs?
什么是仿制药？
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.
仿制药是指在剂型、安全性、规格、给药途径、质量、性能特征和预期用途等方面与已上市的原研药相同的药物。这些相似性有助于证明生物等效性，这意味着仿制药与原研药具有相同的工作方式和提供相同的临床效益。换句话说，你可以用仿制药来代替原研药。
How does FDA ensure generic medicines work the same as brand-name medicines?
FDA如何确保仿制药与名牌药一样有效？
Any generic medicinemust perform the same in the body as the brand-name medicine. It must be the same as a brand-name medicine in dosage, form and route of administration, safety, effectiveness, strength, and labeling (with certain limited exceptions). It must also meet the same high standards of quality and manufacturing as the brand-name product, and it must be and quality, taken and used in the same way as well. This standard applies to all generic medicines.
任何仿制药在体内的作用都必须和原研药一样。在剂量、剂型、给药途径、安全性、有效性、药力、标签等方面必须与原研药品相同(某些有限的例外)。它必须达到与原研产品同样高的质量和制造标准，质量、使用和使用方法也必须相同。该标准适用于所有仿制药。
Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines. The FDA Generic Drugs Program conducts a rigorous review to ensuregeneric medicines meet these standards, in addition to conducting inspections of manufacturing plants and monitoring drug safety after the generic medicine has been approved and brought to market.
仿制药与原研药使用相同的有效成分，作用方式相同，因此具有与原研药相同的风险和益处。FDA仿制药计划进行严格的审查，以确保仿制药符合这些标准，此外，还对仿制药的生产工厂进行检查，并在仿制药获得批准并上市后监测药物安全性。
A generic drug may have certain minor differences from the brand-name product, such as different inactive ingredients.
仿制药与原研药可能有一些细微的差别，比如不同的非活性成分。
It is important to note that there will always be a slight, but not medically significant, level of expected variability—just as there is for one batch of brand-name medicine compared with the next batch of brand-name product. This variability can and does occur during manufacturing, for both brand-name and generic medicines. When a medicine, generic or brand-name, is mass produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.
值得注意的是，总有一个轻微的、但在医学上并不显著的预期差异水平——就像有一批原研药品与下一批原研产品的差异一样。对于原研药品和非专利药品，在生产过程中可能而且确实会出现这种变化。当一种药物，无论是仿制药还是原研药，被大量生产时，在纯度、数量、规格和其他参数上的微小变化是允许的。FDA限制了可变性的可接受程度。
For example, a very large research study1comparing generics with brand-name medicines, found that there were very small differences (approximately 3.5%) in absorption into the body between generic and brand-name medicines. Some generics were absorbed slightly more, some slightly less. This amount of difference is expected and clinically acceptable, whether for one batch of brand-name medicine tested against another batch of the same brand, or for a generic tested against a brand-name medicine.
例如，一项比较仿制药和原研药的大型研究发现，仿制药和原研药在人体吸收方面的差异非常小(约为3.5%)。一些仿制药被吸收的稍微多一些，一些稍微少一些。无论是对一批原研药品与另一批同一原研药品进行对比测试，还是对仿制药与原研药品进行对比测试，这一差异是预期的，并且在临床上是可以接受的。
Why does a generic druglook different from the brand drug?
为什么仿制药和原研药看起来不一样?
Trademark laws in the United States do not allow a generic drugto look exactly like other drugs already on the market. Generic medicines and brand-name medicines share the same active ingredient, but other characteristics, such as colors and flavorings, that do not affect the performance, safety, or effectiveness of the generic medicine, may be different.
美国的商标法不允许仿制药与市场上已经上市的其他药物完全相同。仿制药和原研药具有相同的活性成分，但不影响仿制药性能、安全性或有效性的其他特征，如颜色和香料，可能不同。
Why do generic medicines often cost less than the brand-name medicines?
为什么仿制药往往比原研药便宜?
Generic drugs are approved only after a rigorous review by FDA and after a set period of time that the brand product has been on the market exclusively. This is because new drugs, like other new products, are usually protected by patents that prohibit others from making and selling copies of the same drug.
仿制药只有经过FDA的严格审查，并在原研产品独家上市一段时间后才能获得批准。这是因为新药和其他新产品一样，通常受到专利保护，禁止其他人生产和销售同一种药物的复制品。
Generic drugs tend to cost less than their brand-name counterparts because generic drug applicants do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness. This abbreviated pathway is why the application is called an “abbreviatednew drug application.”
仿制药的成本往往比原研药低，因为仿制药申请人不必重复原研药为证明安全性和有效性而进行的动物和临床(人)研究。这个简要途径就是为什么该申请被称为“简化新药申请”。
The reduction in upfront research costs means that, although generic medicines have the same therapeutic effect as their branded counterparts, they are typically sold at substantial discounts, an estimated 80 to 85% less, compared with the price of the brand-name medicine. According to the IMS Health Institute, generic drugs saved the U.S. healthcare system nearly $2.2 trillion from 2009 to 20192.
前期研究成本的降低意味着，尽管仿制药的治疗效果与原研药相同，但它们的售价通常会有很大的折扣，估计比原研药低80%至85%。根据IMS Health Institute的数据，从2009年到2019年，仿制药为美国医疗系统节省了近2.2万亿美元。
When multiple generic companies are approved to market a single product, more competition exists in the marketplace, which typically results in lower prices for patients.
当多个仿制药公司被批准销售同一种产品时，市场上存在更多的竞争，这通常会导致产品价格更低。
Bringing more drug competition to the market and addressing the high cost of medicines is one of FDA’s top priorities. In 2017, FDA announced the Drug Competition Action Plan (DCAP) to further encourage robust and timely market competition for generic drugs and help bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program.
为市场带来更多的药品竞争，解决药品的高成本问题是FDA的首要任务之一。2017年，FDA宣布了药物竞争行动计划(DCAP)，以进一步鼓励对仿制药进行强有力和及时的市场竞争，并帮助提高仿制药审查过程的效率和透明度，同时不牺牲仿制药计划的科学严谨性。
What standards must generic medicines meet to receive FDA approval?
仿制药必须符合何种标准才能获得FDA批准?
Drug companies must submit an abbreviated new drug application (ANDA) to FDAfor approval to market a generic drug that is the same as (or bioequivalent to) the brand product. FDA reviews the application to ensure drug companies have demonstrated that the generic medicine can be substituted for the brand-name medicine that it copies.
制药公司必须向FDA提交一份简短的新药申请(ANDA)，以便批准销售与原研产品相同(或生物等效)的仿制药。FDA审查申请，以确保制药公司证明仿制药可以替代其复制的原研药。
An ANDA must show the generic medicine is equivalent to the brand in the following ways:
ANDA必须以下列方式证明仿制药与该原研药等效:
The active ingredient is the same as that of the brand-name drug/innovator drug.
有效成分与原研药/创新药相同。
An active ingredient in a medicine is the component that makes it pharmaceutically active — effective against the illness or condition it is treating.
药物中的有效成分是使其具有药物活性的成分——对其治疗的疾病或病症有效。
Generic drug companies must provide scientific evidence that shows that their active ingredient is the same as that of the brand-name medicine they copy, and FDA must review that evidence.
仿制药公司必须提供科学证据，证明其有效成分与仿制的原研药相同，而FDA必须审查这些证据。
The generic medicine is the same strength.
仿制药的药效是一样的。
The medicine is the same type of product (such as a tablet or an injectable).
药物是同一类型的产品(如片剂或注射剂)。
The medicine has the same route of administration (such as oral or topical).
药物的给药途径相同(如口服或外用)。
It has the same use indications.
具有相同的使用适应症。
The inactive ingredients of the medicine are acceptable.
药物中的非活性成分是可以接受的。
Some differences, which must be shown to have no effect on how the medicine functions, are allowed between the generic and the brand-name product.
仿制药和原研药之间允许存在一些差异，但必须证明这些差异对药物的作用没有影响。
Generic drug companies must submit evidence that all the ingredients used in their products are acceptable, and FDA must review that evidence.
仿制药公司必须提交证据，证明其产品中使用的所有成分都是可接受的，而FDA必须审查这些证据。
It lasts for at least the same amount of time.
至少持续相同的时间。
Most medicines break down, or deteriorate, over time.
随着时间的推移，大多数药物会分解或吸收。
Generic drug companies must do months-long "stability tests" to show that their products last for at least the same amount of time as the brand-name product.
仿制药公司必须进行长达数月的“稳定性测试”，以表明其产品的保质期至少与原研产品相同。
It is manufactured under the same strict standards as the brand-name medicine.
是按照与原研药品相同的严格标准生产的。
It meets the same batch requirements for identity, strength, purity, and quality.
满足相同批次的鉴别，规格，纯度和质量的要求。
The manufacturer is capable of making the medicine correctly and consistently.
生产商有能力正确而稳定地生产该药。
Generic drug manufacturers must explain how they intend to manufacture the medicine and must provide evidence that each step of the manufacturing process will produce the same result each time. FDA scientists review those procedures, and FDA inspectors go to the generic drug manufacturer's facility to verify that the manufacturer is capable of making the medicine consistently and to check that the information the manufacturer has submitted to FDA is accurate.
仿制药生产商必须说明他们打算如何生产药物，并必须提供证据证明生产过程的每一步都会产生相同的结果。FDA的科学家审查这些程序，FDA检查员前往仿制药生产商的工厂，以核实生产商有能力持续生产药物，并检查生产商提交给FDA的信息是否准确。
Often, different companies are involved (such as one company manufacturing the active ingredient and another company manufacturing the finished medicine). Generic drug manufacturers must produce batches of the medicines they want to market and provide information about the manufacturing of those batches for FDA to review.
通常涉及不同的公司(例如一家公司生产活性成分，另一家公司生产成品药)。仿制药生产商必须生产他们想要销售的药品的批次，并向FDA提供这些批次的生产信息以供审查。
The container in which the medicine will be shipped and sold is appropriate.
药品装运和销售的容器是合适的。
The label is the same as the brand-name medicine's label.
标签和原研药的标签要一致。
The drug information label for the generic medicine should be the same as the brand-name label. One exception is if the brand-name drug is approved for more than one use and that use is protected by patents or exclusivities. A generic medicine can omit the protected use from its labeling and only be approved for a use that is not protected by patents or exclusivities, so long as that removal does not take away information needed for safe use. Labels for generic medicines can also contain certain changes when the drug is manufactured by a different company, such as a different lot number or company name.
仿制药品的药品信息标签应与原研药品标签相同。一个例外是，如果原研药物被批准用于一种以上的用途，并且该用途受到专利或专有权的保护。仿制药可以在其标签上省略受保护的用途，并且只有在不受专利或专有权保护的情况下才能获得批准，只要这种删除不省略安全使用所需的信息。当药品由不同的公司生产时，仿制药的标签也可能包含某些变化，例如不同的批号或公司名称。
Relevant patents or exclusivities are addressed.
涉及相关专利或专有权。
As an incentive to develop new medicines, drug companies are awarded patents and exclusivities that may delay FDA approval of applications for generic medicines. FDA must comply with the delays in approval that the patents and exclusivities impose.
为了鼓励开发新药，制药公司被授予专利和专有权，这可能会推迟FDA对仿制药申请的批准。FDA必须遵守专利和排他性带来的批准延迟。
The ANDA process does not, however, require the drug applicant to repeat costly animal and clinical (human studies) on ingredients or dosage forms already approved for safety and effectiveness. This allows generic medicines to be brought to market more quickly and at lower cost, allowing for increased access to medications by the public.
然而，ANDA过程并不要求药物申报人重复对已批准的安全性和有效性的成分或剂型进行昂贵的动物和临床(人体研究)。这使得仿制药能够以更低的成本更快地推向市场，增加公众获取药物的机会。
Is a genericof my brand-name medicine available?
怎么得知该原研药是否有仿制药？
In addition to asking your local pharmacist for assistance, there are three ways to find out if there is a genericof your brand-name medicine available:
除了向当地的药剂师寻求帮助外，还有三种方法可以确定你的原研药是否有仿制药:
Use Drugs@FDA, a catalog of FDA-approved drug products, including their drug labeling.
使用Drugs@FDA，一个FDA批准的药品目录，包括它们的药品标签。
oFirst, search by brand name.
o首先，搜索原研名称。
oSecond, select the brand name product and note which products are listed under the section labeled “Therapeutic Equivalents for ...”
o其次，选择原研产品，并注意哪些产品列在“治疗等效产品”一栏。
oProducts that include an ANDA(not NDA) number next to the name are generic products.
oo名称旁边包含ANDA(非NDA)编号的产品为通用产品。
Use the online version of the .
使用Orange Book的在线版本。
oFirst, search by proprietary or brand name. Note the active ingredient name.
o首先，搜索专有或原研名称。注意活性成分的名称。
oSecond, search again by the active ingredient name.
o第二，再次搜索活性成分的名称。
oScroll right to find the dosage form (for example: tablet) and strength.
o向右滚动查找剂型(例如:片剂)和剂量。
oNext, scroll right to the TE Code column. If the TE column contains a code beginning with “A,” FDA has approved generic equivalents.
o下一步，向右滚动到TE Code列。如果TE列包含以“a”开头的代码，则FDA已批准仿制药。
oFinally, look at the column“Appl No.” If the letter “A” appears before the number, that product is an FDA-approved generic for the brand-name drug.
o最后，看看“申请No”这一栏。如果字母“A”出现在数字前，那么该产品就是FDA批准的该原研药物的仿制药。
oFor very recent approvals，consult First Generic Drug Approvals.
o关于最近的批准，请咨询第一批仿制药批准。
If you are unable to locate a genericof your brand-name medicine, it may be that the brand-name medicine is still within the period of time when it has exclusive rights to the marketplace, which allows drug companies to recoup their costs for the initial research and marketing of the brand-name or innovator drug. It is only after both patent and other periods of exclusivity are resolved that FDA can approve a generic of the brand-name medicine.
如果您无法找到原研药物的仿制药，可能是该原研药物仍在拥有市场独占权的期限内，这使制药公司可以收回其对该原研或创新药物的最初研究和营销成本。只有在专利期和其他专有权期解决后，FDA才能批准该原研药物的仿制药。
How Does FDA monitor side effects or safety issues with generic medicines?
FDA如何监测仿制药的副作用或安全问题?
FDA takes several actions to ensure safety and quality before and after a new or generic medicine is approved. When a generic drug application is submitted, FDA conducts a thorough examination of the data submitted by the applicant and evaluates information obtained by FDA investigators while inspecting the related testing and manufacturing facilities to ensure that every generic drug is safe, effective, high quality, and substitutable to the brand name drug.
FDA在新药或仿制药获得批准之前和之后会采取一些措施来确保安全性和质量可控性。当仿制药申请提交时，FDA会对申请人提交的数据进行彻底的审查，并评估FDA调查人员获得的信息，同时检查相关的测试和生产设施，以确保每一种仿制药都是安全、有效、高质量的，并可替代原研药。
FDA staff continually monitors all approved drug products, includinggenerics, to make certain the medicines at all levels of the supply chain, from active pharmaceutical ingredients (APIs) to products being sold to consumers, are safe, effective, and high quality.
FDA工作人员持续监控所有批准的药品，包括仿制药，以确保供应链各个层面的药品，从活性药物成分（API）到销售给消费者的产品，都是安全、有效和高质量的。
FDA also monitors and investigates reports of negative patient side effects or other reactions. The investigations may lead to changes in how a product (brand-name and generic) is used or manufactured, and FDA will make recommendations to health care professionals and the public if the need arises.
FDA还监测和调查患者不良反应或其他反应的报告。调查可能会导致一种产品(原研和仿制药)的使用或生产方式的改变，如果需要，FDA将向卫生保健专业人员和公众提出建议。
MedWatchis the FDA’s medical product safety reporting program. Health professionals, patients and consumers can use MedWatch to voluntarily report a serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that is suspected to be associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic.
medwatch是FDA的医疗产品安全报告程序。卫生专业人员、患者和消费者可以使用MedWatch自愿报告严重不良事件、产品质量问题、产品使用/用药错误或治疗不等效/失败，怀疑与FDA监管的药物、生物制品、医疗设备、食品添加剂或化妆品的使用有关。
Where can I find more information about generic medicines?
在哪里可以找到更多关于仿制药的信息?
Contact your doctor, pharmacist, or other health care provider for information on generic medicines. For more information, you can also:
请与医生、药剂师或其他医疗保健提供者联系，以获取仿制药的信息。欲了解更多信息，还可以:
Visit the FDA Generic Drugs Program
访问FDA仿制药计划
Call 1-888-INFO-FD
致电1-888-INFO-FD
以上内容来源于FDA官网：https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers#top
