Learn about Generic Drugs

What are generic drugs?

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 its brand-name version. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.

How 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

How USFDA approve the generic drug?

As per USFDA these drugs falls under “abbreviated new drug application (ANDA)”. Pharma companies who need approval to sell generic drugs in US market should submit the all supportive documents (ANDA application file) to USFDA. Once approved, an applicant may manufacture and market the generic drug product.

Why Generic drug applications are termed as "abbreviated”?

Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.

How applicants prove that generic medicines work the same as brand-name medicines

Generic applicants scientifically demonstrate that their product is performs in the same manner as the innovator drug. Applicant should conduct the “bioequivalence study” of generic drug which gives the rate of absorption, or bioavailability, of the generic drug, which can then be compared to that of the innovator drug. To be approved by FDA, the generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.  These studies should be conducted in healthy volunteers.

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.

When generic medicines can be sold in the market

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. 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.

Can I know current list of approved generic drugs?

Yes, all approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

Source

https://www.fda.gov/Drugs/DevelopmentApprovalProcess