Biopharmaceutical

A biopharmaceutical, also known as a biological medical product, or biologic, is any <a href="/facts/Pharmaceutical_drug/h9mhwWP2">pharmaceutical drug</a> product manufactured in, extracted from, or <a href="/facts/Semisynthesis/nEMoPxhv">semisynthesized</a> from <a href="/facts/Biology/1M1ee3pB">biological</a> sources. Different from <a href="/facts/Total_synthesis/3GGoqhBm">totally synthesized</a> pharmaceuticals, they include <a href="/facts/Vaccine/QcXzLug2">vaccines</a>, <a href="/facts/Whole_blood/vcoBYMSr">whole blood</a>, blood components, <a href="/facts/Allergenic/bnM4cttq">allergenics</a>, <a href="/facts/Somatic_cell/Emn7gk9A">somatic cells</a>, <a href="/facts/Gene_therapy/CaxRLfKM">gene therapies</a>, <a href="/facts/Tissue_(biology)/H7CpML7A">tissues</a>, <a href="/facts/Recombinant_proteins/dT3PL7M6">recombinant therapeutic protein</a>, and <a href="/facts/Living_medicine/zXVJwKg3">living medicines</a> used in <a href="/facts/Cell_therapy/fFD7A6yN">cell therapy</a>. Biopharmaceuticals can be composed of <a href="/facts/Sugar/jb5KXRHT">sugars</a>, <a href="/facts/Protein/Jxmagu3E">proteins</a>, <a href="/facts/Nucleic_acid/2tTgcI0v">nucleic acids</a>, or complex combinations of these substances, or may be living cells or tissues. They (or their <a href="/facts/Precursor_(chemistry)/dUw8Mx2Y">precursors</a> or components) are isolated from <a href="/facts/Life/DNw7NUId">living</a> sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine.
Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. The term biologics is often used more restrictively to mean biopharmaceuticals that are produced using <a href="/facts/Recombinant_DNA/dT3PL7M6">recombinant DNA</a> technology. 
Some <a href="/facts/Regulatory_agency/VXSrsDSM">regulatory agencies</a> use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered <a href="/facts/Macromolecule/039ULSLg">macromolecular</a> products like protein- and <a href="/facts/Nucleic_acid/2tTgcI0v">nucleic acid</a>-based <a href="/facts/Drug/FFFUI9n4">drugs</a>, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source. Biopharmaceutics is <a href="/facts/Pharmaceutics/ms5hhrMv">pharmaceutics</a> that works with biopharmaceuticals. Biopharmacology is the branch of <a href="/facts/Pharmacology/4Rx8s7Ie">pharmacology</a> that studies biopharmaceuticals. <a href="/facts/Specialty_drugs/XXVMGKFV">Specialty drugs</a>, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. The <a href="/facts/European_Medicines_Agency/h9FTtCYc">European Medicines Agency</a> uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are "based on genes, cells, or tissue engineering", including gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines, and combinations thereof. Within EMA contexts, the term advanced therapies refers specifically to ATMPs, although that term is rather nonspecific outside those contexts.
Gene-based and cellular biologics, for example, often are at the forefront of <a href="/facts/Biomedicine/DWFT3MFG">biomedicine</a> and <a href="/facts/Biomedical_research/lSVBFxDJ">biomedical research</a>, and may be used to treat a variety of medical conditions for which no other treatments are available.
Building on the market approvals and sales of recombinant virus-based biopharmaceuticals for veterinary and human medicine, the use of engineered plant viruses has been proposed to enhance crop performance and promote sustainable production.
In some jurisdictions, biologics are regulated via different pathways from other small molecule drugs and <a href="/facts/Medical_device/uzUHp474">medical devices</a>.

Biopharmaceutical open-in-new

Biopharmaceutical