Generic BIOPHARMA: Generic Biopharmaceuticals, Biosimilars, Follow-on Biologics, Biogenerics, Follow-on Proteins, Biocomparables, Off-patent Biopharmaceuticals

Glossary: Proposed Simple Definitions for 'Biosimilar' and Related Terms

biotechnology: involving manufacture of products using living organisms, generally involving active biotransformation (bioprocessing)
biopharmaceutical: involving pharmaceuticals manufactured using biotechnology
drug: involving pharmaceuticals (chemical substances) manufactured using chemical technology (not biotechnology/living organisms)
follow-on biologic: rather similar (in terns of active agents and indications) biopharmaceuticals only marketable after expiration of reference product-related patents and data and market exclusivities; includes biosimilars, biobetters and biogenerics
biosimilar: similar (in terms of active agent and indications) biopharmaceuticals (follow-on biologics) approved or on track for approval by biosimilar approval pathway(s)
biobetter: similar (in terms of active agent and indications) biopharmaceuticals (follow-on biologics) too dissimilar relative to their reference product to receive approvals through formal biosimilar approval pathways, i.e., these products receive full approvals, e.g, BLAs in the U.S. These products often involve modifications of the active agents or delivery systems.
[Note, despite widespread use, "biobetters" is a very poor and misleading term, with biobetters likely never compared analytically or in clinical trials against their reference product, rather trials are generally placebo-controlled. If only because the product is new, it is commonly assumed to be 'better.']
biogeneric: follow-on biopharmaceuticals portrayed or simply used as being identical, an interchangemable generic equivalent, of a reference product; Currently, these only include products marketed in lesser- or non-regulated international markets; Optionally, may refer to biopharmaceuticals approved as generic drugs [e.g., 505(b)(2) mechanism]
With FDA rather explicitly stating that approval of a biosimilar with interchangeability (considered fully equivalant/same) is a long way off and the EU likely taking the same stance, it will be some time before a biosimilar is approved as s biogeneric in US/EU markets; Thus, 'biogenerics' is, at least for now, best used to just refer to follow-on biologics marketed in un- or lesser-regulated international commerce (where generic equivalence is often simply presumed)
reference product: an already-approved biopharmaceutical either:
a) used for comparisons (in analytical and clinical testing) to support approval as a biosimilar;
b) the already-approved biopharmaceutical against which a rather similar 'biobetter' (full approval product) will compete.
For further information about biosimilar and biopharmaceutical terminology, definitions and nomeclature, see U.S. BIOPHARMACOPEIA Registry of Biopharmaceutical Products.

Contact/Further Information:

Ronald A. Rader
President
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
E-Mail: biotech@biopharma.com
Phone: 301-424-0255 (9AM-5PM, Eastern U.S.)