What are generics?

Generics are medications sold under the product's chemical, or "generic," name after the patent has expired on the equivalent, branded medication.

When a new medicine is developed, the pharmaceutical company discovering the product and introducing it into the market is afforded a period of patent protection on that medicine. When the patent expires, other pharmaceutical companies can seek approval from the U.S. Food and Drug Administration (FDA) to market an equivalent product under its chemical, or "generic," name. In some cases, generics may enter the market before the patent expires if that patent is shown to be invalid or if the generic version does not infringe on the patent.

Generics are required by the FDA to have the same active ingredients, indications, dosing and dosage form, labeling, strength and route of administration as the brand product. Generics must also meet the same batch-to-batch requirements for strength, purity and quality; and they must be manufactured under the same strict good manufacturing practice regulations as the brand drug.

Why use generics?

More and more consumers are embracing generic drugs as a safe, effective and affordable alternative to brand-name prescription drugs. According to IMS Health, Inc. in 2005, generics represented 56% of all prescriptions dispensed, but only 13% of the total cost of pharmaceuticals. That same year, the average price of a generic prescription drug was $29.82, while the average price of a brand-name prescription drug was $101.71 (Source: The National Association of Chain Drug Stores, 2006 Chain Pharmacy Industry Profile).

Generics are used to fill more than one billion prescriptions every year, and currently 8,730 of the 11,487 drugs listed in the FDA's Orange Book have generic counterparts. Today the blend of brand and generic pharmaceuticals allows Americans to live longer, healthier lives.

What are biopharmaceuticals?

Biopharmaceuticals are drugs that are derived from living sources, as opposed to traditional drugs that are chemically synthesized. Biopharmaceuticals are used in the fight against cancer, viral infections, diabetes, hepatitis, multiple sclerosis and many other conditions and diseases. Antibiotics, insulins, interferons, estrogens, therapeutic serums, human growth hormone, proteins produced by recombinant DNA technology and classical vaccines, such as Polio and DPT vaccines, are all biopharmaceuticals.

Why do we need generic biopharmaceuticals (biogenerics)?

Given the technology that is necessary to produce biopharmaceuticals, prices of these products are exceedingly high in contrast to traditional pharmaceuticals. For example, treatment with Genentech’s colon and breast cancer drug Avastin® costs $100,000 per year, while Cerezyme®, a drug used to treat a genetic condition, is priced at an average of $170,000 per patient per year. Access to affordable, generic versions of these biopharmaceuticals will alleviate the resulting financial stress on our nation's health care system and allow all Americans to enjoy the benefit of these advances in biotechnology.