Biopharmaceuticals: Definitions of Terms

Dr. LaFleur is a research assistant professor in the department of pharmacotherapy, University of Utah College of Pharmacy Pharmacotherapy Outcomes Research Center.

Biotechnology is a new science that still lacks adequately developed supporting laws about generic competition;consequently, the field is afloat with controversy. Emerging language to describe this field is confusing to manypharmacists.

This glossary contains explanations for some common biotechnology and biopharmaceutical terms to help pharmacistsnavigate this science. We need to understand these terms to communicate with our patients about the biogenerics controversy.

Glossary of Terms

Biocomparable

• A common synonym for biogeneric
• Avoid this term because of possible confusion with the term comparability (see below), which applies to changes in the manufacturing processes for innovator biopharmaceuticals

Biogeneric

• A biopharmaceutical considered to be generic, eg, not the innovator biopharmaceutical product

Biologic

• A substance derived from animal products or other biological sources that is used to treat or prevent disease
• A regulatory term related to FDA approval for biopharmaceuticals and associated products; includes allbut the simplest biopharmaceuticals regulated as drugs by the FDA; biologics are approved by CBER

Biopharmaceutical

• A pharmaceutical product that is manufactured using live organisms and has an active ingredient that is biological in nature

Biosimilar

• A biogeneric approved in the European Union; new versions of innovator biopharmaceutical products officially approved following patent expiration of the innovator product
• Short term for similar biotechnology medicinal product

Comparability

• An official judgment of similarity between a biopharmaceutical following a change in the manufacturing process and the same product before any change in the manufacturing process
• Implies regulatory acceptability and regulatory approval

Drug

• A pharmaceutical product with an active ingredient that is manufactured using chemical?not biological?methods
• Includes the vast majority of pharmaceuticals; drugs are approved by CDER

Follow-on

• A common biogeneric synonym
• A later version of a biopharmaceutical, often a more technologically advanced version of an innovatorproduct; see later generation
• Avoid this term because of possible confusion with follow-on protein, a regulatory term related to FDAapproval of biopharmaceutical proteins

Follow-on protein

• A biopharmaceutical approved or on track to be approved by the FDA as a generic drug
• Generally restricted to relatively simple proteins, including those with prior versions that wereapproved as natural products

Follow-on biologic

• A biopharmaceutical approved or on track to be approved by the FDA as a generic biopharmaceutical
• This regulatory track does not yet exist

Innovator

• An original product and its associated manufacturer
• Usually, the innovator is the first to receive regulatory approval
• Innovator products generally provide original, extensive research and development and conduct fullunabbreviated phase 3 safety and efficacy trials

Later generation

• A biopharmaceutical similar to another prior product
• Usually refers to a product to which technological advances or other modifications have been appliedsuch that it differs from the innovator product
• Use this term in place of follow-on

Pharmaceutical

• A medicinal product
• Encompasses drugs and biopharmaceuticals

CBER = Center for Biologics Evaluation and Research

CDER = Center for Drug Evaluation and Research.

Source: Rader RA. What are generic biopharmaceuticals? Biogenerics? Follow-on proteins? Biosimilars? Follow-on biologics? Biopharma Web site. www.biopharma.com/whatisabiogeneric.html. Accessed April 25, 2008.