Biopharming / Biopharming glossary
Biopharming – also known as plant molecular farming – refers to the production and harvest of plants that have been genetically modified to express specific bioactive molecules that are used to make a wide range of pharmaceuticals (e.g., therapeutic proteins, monoclonal antibodies and vaccines) as well as other industrial products.
A biopharmaceutical is a general category of pharmaceuticals that refers to drug products made or extracted from a living organism (e.g., humans, animals, microorganisms or yeast). Recombinant therapeutic proteins, monoclonal antibodies and vaccines are some examples of biopharmaceuticals – they are large (and often very complex) molecules, unlike chemically synthesized (small molecule) pharmaceuticals. See Biopharmaceutical in Wikipedia for more information.
Plant-made pharmaceuticals (PMPs) are biopharmaceuticals producing using plant-based systems (also known as biopharming). PMPs are the result of innovations in biotechnology that make it possible to genetically engineer plants to produce therapeutic proteins for a wide range of medicines. The plants are grown under highly regulated conditions in controlled environment systems, using a variety of processes that, in effect, turn the plants into factories or bioreactors that produce a target protein. After the plants are harvested, the proteins are extracted and purified for use in the production of medicine, often at a fraction of the cost of similar drugs derived from mammalian cell-culture and bacterial production systems. Plant-made pharmaceuticals are also known more generally as biologics (biological products).
Biologic (Biological product)
A biologic or biological product is another term for biopharmaceutical – a large molecule drug made using a biological process.
Biosimilar (Subsequent entry biologic / Follow-on biologic)
A biosimilar product is a highly similar version of an already-approved brand-name (innovator) biologic drug product, known as a reference product. According to the U.S. FDA, a biosimilar must demonstrate it has “no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.”
Other terms for biosimilars are follow-on biologics and subsequent-entry biologics. See Biosimilar in Wikipedia for more information.