DIFFERENCE BETWEEN THE BRANDED AND GENERIC DRUGS

Brand Name Drugs

• Also called “innovator drugs”
• Initially marketed as new chemical entities
• First version sold by the innovator manufacturer

Generic Drugs

• Copies of brand name drugs
• Produced after the original patent expires  

Companies wishing to sell the generic drug have much lower development costs (they do not have the high costs of marketing that brand names spent on advertising... the drug is already known), they can produce it at a lower unit cost, sell it for less and still make a profit on the sale. The FDA regulates manufacture of both brand-name and generic drugs and the overall quality should be comparable.
The difference between a brand-name product and a generic one is designed to be transparent. Once the patent life expires on a brand-name drug product, it is eligible to be made into a "generic drug." To do this, the generic drug manufacturer must ensure that the drug they are producing contains the same active ingredient(s) as the brand-name product, in the same dosage form, at the same dose or concentration, and for the same route of administration (for example, amoxicillin 500 milligram (oral) capsule). The drug may differ in color, shape, taste, inactive ingredients, preservatives and packaging, however. Because of these differences, the generic drug manufacturers are required to submit additional paperwork to the FDA to prove that their product is manufactured in accordance with good manufacturing practices (GMPs), and is as pure and stable as the brand-name product. Additionally, the generic needs to meet pharmacokinetic parameters in the body, which means it must dissolve (in a beaker) at the same rate and to the same extent as the original. This process ensures that the two products are bioequivalent because if product A and product B dissolve in a virtually identical manner, then they should behave the same in the body.

Overview & Basics

                                                
The Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications:

• Contain the same active/key ingredient;
• Have the same strength;
• Use the same dosage form (for instance, a tablet, capsule, or liquid); and
• Use the same route of administration (for instance, oral, topical, or injectable).

FDA's review process ensures that generic medications perform the same way in the human body and have the same intended use as the name brand medication. Health care professionals and consumers can be assured that FDA-approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs. In addition, FDA inspects facilities to make certain the generic manufacturing, packaging, and testing sites pass the same quality standards as those of brand-name drugs.

Patient Education

Generic medications are just as safe and effective as their brand-name counterparts, and often cost less.  While nearly 9 in 10 prescriptions filled are for generics, many people have questions about whether they are really as good as the name brand medications and, if so, why there is a cost savings. To help educate patients about FDA’s rigorous review process, the economics of pricing, and related issues, FDA offers a range of educational materials, including videos, graphics, fact sheets, and related resources. Information and materials about generic drugs are also available in Spanish.

A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics.

 

Generic medicines work the same as brand-name medicines
A generic medicine works in the same way and provides the same clinical benefit as its brand-name version. This standard applies to all FDA-approved generic medicines. A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and should be used.

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 make sure generic medicines meet these requirements. In addition, FDA conducts 3,500 inspections of manufacturing plants a year, ensuring compliance with the agency's regulations on good manufacturing practices.
FDA staff also continually monitor drug products to make certain the medicines at all levels of the supply chain, from active pharmaceutical ingredients (API) to products being sold to consumers, are safe, effective, and high quality. In the event of reports of negative patient side effects or other reactions, the FDA investigates and, when appropriate, may require changes in how a medicine (both brand-name and generic versions) is used or manufactured.

 Generic drugs must meet high standards to receive FDA approval
FDA requires drug companies to demonstrate that the generic medicine can be effectively substituted and provide the same clinical benefit as the brand-name medicine that it copies. The abbreviated new drug application (ANDA) submitted by drug companies must show the generic medicine is the same as the brand-name version in the following ways:

• The active ingredient in the generic medicine is the same as in the brand-name drug/innovator drug.
• The generic medicine has the same strength, use indications, form (such as a tablet or an injectable), and route of administration (such as oral or topical).
• The inactive ingredients of the generic medicine are acceptable.
• The generic medicine is manufactured under the same strict standards as the brand-name medicine.
• The container in which the medicine will be shipped and sold is appropriate, and the label is the same as the brand-name medicine's label.

To learn more about how FDA reviews generic medicines, visit What Is the Approval Process for Generic Drugs?

Approved generic medicines are generally only sold after patents and exclusivities protecting the brand-name version end
Patents and exclusivities are forms of protection for drug makers that may affect how and when a generic drug is approved and can be sold. New brand-name drugs are usually protected by patents (issued by the U.S. Patent and Trademark Office) that prohibit others from selling generic versions of the same drug. Periods of marketing exclusivity for brand-name drugs can also impact the approval of generic drugs.
FDA must comply with the delays in approval that the patents and exclusivities impose. Once these patents and marketing exclusivities expire (or if the patents are successfully challenged by the generic drug company), the generic drug can receive full approval and can be sold.

Generic medicines cost less than brand-name medicines
Generic medicines tend to cost less than their brand-name counterparts because they do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness. In addition, multiple applications for generic drugs are often approved to market a single product; this creates competition in the marketplace, typically resulting in lower prices.
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 substantially lower costs. When multiple generic companies market a single approved product, market competition typically results in prices about 85% less than the brand-name. According to the IMS Health Institute, generic drugs saved the U.S. health care system $1.67 trillion from 2007 to 2016.
To learn more about pricing, visit Generic Competition and Drug Prices.

How are generic and brand name drugs the same?

Generic and brand name drugs have identical active ingredients.
Bioequivalent drug formulations have the same bioavailability; that is, the same rate and extent of absorption. New drug formulations must meet standards set by Health Canada. If the generic drug is bioequivalent, it is assumed that it will produce the same therapeutic effect as the brand name drug. This means that new clinical studies are not needed for generic drugs.
There is a common misperception that generic drug concentrations can be 80% to 125% of the brand name formulation; in other words, that the variance may be up to 45%. This is not true.

• One of the key parameters for bioequivalence is the area under the curve (AUC). The AUC is a mathematical calculation based on a graph of blood concentration versus time, and it correlates well with total drug exposure.
• The AUC of a generic formulation must be no less than 80% or no more than 125% of the brand name formulation. There is international consensus that differences within this range are not clinically significant.
• More importantly, the 90% confidence interval of the AUC must also fall within 80% to 125%. Recall that the confidence interval is a range of measurements within which we can be confident that the true result lies. So, for the entire confidence interval to fall within the 80% to 125% range, the variance is generally less than 5%.

How are generic and brand name drugs different?

Although the active ingredients are the same, the excipients (inactive ingredients) may differ. This is only important in rare cases when a patient has an allergy or sensitivity to one of the excipients.
The product may also be slightly different in colour, shape, or markings.
The biggest difference is cost. Generic drugs are generally less expensive than brand name comparators.

What about critical dose drugs?

A few drugs that are highly toxic or have a narrow therapeutic range are known as critical dose drugs. Examples are cyclosporine, digoxin, flecainide, lithium, phenytoin, sirolimus, tacrolimus, theophylline, and warfarin. Health Canada sets different standards for these drugs. Bioequivalence requirements for critical dose drugs are stricter than for other drugs.
For drugs with a narrow therapeutic range such as antiepileptics and antiarrhythmics, there have been anecdotal reports of differences between brand name and generic drugs. However, controlled trials looking for increased toxicity or exacerbation of disease have consistently failed to show clinically important differences.

 

 

What about biologics?

Biologics are a class of drugs derived through the metabolism of living organisms, rather than being synthesized in a laboratory. Biologics include insulin analogues, interferons, erythropoietin, and monoclonal antibodies such as infliximab or adalimumab.
Subsequent entry biologics (SEBs) are new versions of biologics that come to the Canadian market after the patent for the original product has expired. Unlike generic drugs, SEBs are not equivalent to the innovator drug because their chemical characteristics cannot be precisely duplicated during the manufacturing process.
Health Canada reviews each SEB as if it were a new drug. It does not consider an SEB to be bioequivalent or interchangeable with the innovator product.

 

 

Bottom Line:

• Generic and brand name drugs are bioequivelant.
• Clinically important differences have not been reported in well-controlled trials.
• Generic drugs create savings that can be redirected elsewhere.

References

• Canadian Health Services Research Foundation [Internet]. Ottawa: CHSRF. Myth: generic drugs are lower-quality and less safe than brand-name drugs; 2007 Jun [cited 2011 Dec 1]. Available from: http://www.chsrf.ca/PublicationsAndResources/Mythbusters/ArticleView/07-06-01/0f090ed6-335a-463a-8cf0-55df449fc2c8.aspx
• Kesselheim AS. CMAJ [Internet]. 2011 Sep 6 [cited 2011 Dec 1];183(12):1350-1. Available from: http://www.cmaj.ca/content/183/12/1350.full.pdf+html
• Henney JE. JAMA. 1999 Dec 1;282(21):1995
•  FDA Gov.