A National Consumers League Stakeholder Forum

Biologics: The Pathway to Biosimilar Products?

September 18, 2007

AFL-CIO Building

Presidents Room, First Floor 

815 16^th Street, NW

Washington, DC

Glossary of Biosimilar Biologic Terms

Abbreviated clinical trials - shortened and less extensive clinical trials compared to full-length clinical trials. 

Bioequivalence – term used when the active ingredients of two products are the same, and the rate and extent of absorption into the body are the same. It is used to describe a generic drug product that performs in the same manner as the innovator, or brand, drug product.

Biologic drug – substance made from a living organism or its products and used in the prevention, diagnosis, or treatment of certain health conditions (e.g., cancer, multiple sclerosis, lupus).

Biosimilar biologic drug - lower cost copies of biologic drugs (also sometimes called generic or follow-on drugs). Currently, these products are not available in the United States because no regulation exists to develop or approve them through the U.S. Food and Drug Administration (FDA).

Comparability and sameness – terms used to describe the bioequivalence between two products.

Exclusivity – length of time that the manufacturer of a drug product has exclusive rights to that product in the market (no generic versions of that product can be sold during that period). Terms of exclusivity are defined in the drug patent issued by the FDA.

Generic drug – lower cost copy of an innovator, or brand, drug. A drug product that is comparable to an innovator, or brand, drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use. Produced and distributed without patent protection.

Interchangeability – the substitution of a generic or biosimilar biologic product for its branded counterpart when the two products are functionally the same.  

Patent – gives a certain number of years of protection to the manufacturer of innovator, or brand, drugs. In the U.S. pharmaceutical market, a patent gives 20 years of protection to the manufacturer of an innovator drug. It is applied for through the FDA before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years. In most cases, generic products are not available until patent protections given to the original developer have expired (exclusivity term ends).  

Pharmaceutical drug – substance made from chemicals and used in the prevention, diagnosis, or treatment of certain health conditions (e.g., high cholesterol, depression, allergies).

Post-marketing follow-up/surveillance – active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed drug. The data can reveal unforeseen adverse events, the actual rate of anticipated adverse events, or other information necessary to protect the public health.