II. Definitions

  1. Biologic Agents
    1. Pharmaceutical preparations manufactured within biologic systems (e.g. microorganisms)
    2. Contrast with classical drugs that are chemically synthesized
  2. Biosimilars
    1. Biologic agents that are similar to the original or reference biologic agent, but not exact duplicates
      1. Manufacturers of Biosimilars are not required to show FDA similar efficacy to reference agents
      2. Biosimilars tend to cost up to one third less of the original reference agents
    2. Examples
      1. Neupogen (filgrastim) has 2 Biosimilars (Nivestym, Zarxio)
      2. Remicade (Infliximab) has 2 Biosimilars (Inflectra, Renflexis)
      3. Neulasta (pegfilgrastim) has the biosimilar Fulphila

III. Types: Biologic Drug Name Interpretations

  1. Biologic Agent naming conventions have changed over time
    1. Transitioning from an older source system naming (e.g. Xi), to a target system naming (e.g. fung)
    2. Older example: Tras-tu-zu-mab (anti-tumor, humanized mononclonal Antibody)
    3. Newer example: benra-li-zu-mab (immune-targeted, humanized Monoclonal Antibody)
  2. Suffix
    1. Mab: Monoclonal Antibody
    2. Cept: Protein that mimics an Immunoglobulin
  3. Pre-Suffix
    1. U: All human origin
    2. O: Mouse cell origin
    3. Zu: Humanized origin
    4. Xi: Mixed or chimeric (part human and part non-human origin)
  4. Middle, Bridging Syllable
    1. T: Tumor target
    2. So: Bone target
    3. Ci: Circulation target
    4. Gro: Growth factor target
    5. Ba: Bacterial target
    6. Fu: Fungal target
    7. Vi: Virus
    8. Ki: Interleukin target
    9. Li: Immune target
    10. Toxa: Toxin target
  5. References
    1. Nomenclature of monoclonal antibodies (Wikipedia)
      1. https://en.wikipedia.org/wiki/Nomenclature_of_monoclonal_antibodies

IV. Types: Monoclonal Antibody

  1. Identical antibodies that are synthesized by a single immune cell type
  2. Synthesized in labs to be targeted at disease-specific molecules
    1. Rheumatoid Arthritis
    2. Psoriatic Arthritis
    3. Inflammatory Bowel Disease (Crohn's Disease, Ulcerative Colitis)
    4. Targeted Cancer Therapy
      1. Monoclonal Antibody-Mediated Chemotherapy
      2. Small Molecule Inhibitor-Mediated Chemotherapy

V. Adverse Effects

  1. Most targeted biologic agents (e.g. monoclonal antibodies) have the potential for serious adverse effects
    1. Adverse effects fall in general patterns, but each agent also may have specific side effects
  2. Infectious disease
    1. Live Vaccines are contraindicated
    2. Decreased cellular immunity
      1. Tuberculosis
      2. Sepsis
      3. Systemic fungal infection
      4. Hepatitis B activation
      5. Progressive Multifocal Leukoencephalopathy or PML (polyoma virus)
      6. Disseminated Herpes Zoster
  3. Neurologic syndromes
    1. Multiple Sclerosis
    2. Seizures
    3. Guillain Barre
  4. Hematologic Effects
    1. Aplastic Anemia or other Pancytopenia
  5. Malignancy
    1. Non-Melanoma Skin Cancer
    2. Lymphoma
  6. Miscellaneous
    1. Pneumonitis
    2. Thyroid disease

VI. References

  1. Swadron and Mallon in Herbert (2018) EM:Rap 18(11): 7-8

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Related Studies

Ontology: Monoclonal Antibodies (C0003250)

Definition (MSH) Antibodies produced by a single clone of cells.
Definition (NCI) An antibody produced by a clone or genetically homogenous fast-growing cells i.e., hybridoma. Hybridoma cells are cloned to establish cell lines producing a specific antibody that is chemically and immunologically homogeneous. They are widely used in cancer detection, diagnosis, and treatment.
Definition (NCI_NCI-GLOSS) A type of protein made in the laboratory that can bind to substances in the body, including tumor cells. There are many kinds of monoclonal antibodies. Each monoclonal antibody is made to find one substance. Monoclonal antibodies are being used to treat some types of cancer and are being studied in the treatment of other types. They can be used alone or to carry drugs, toxins, or radioactive materials directly to a tumor.
Definition (CSP) homogeneous antibody that is produced by a clone of antibody forming cells and that binds with a single antigenic determinant.
Concepts Immunologic Factor (T129) , Amino Acid, Peptide, or Protein (T116)
MSH D000911
SnomedCT 312312006, 49616005
English Antibodies, Monoclonal, MoAB, Antibodies, Monoclonal [Chemical/Ingredient], Monoclonal antibodies, monoclonal antibody, Monoclonal antibody, Monoclonal antibody (substance), monoclonal antibodies, MAb, Monoclonal Antibody, Monoclonal Antibodies
Swedish Monoklonala antikroppar
Finnish Monoklonaaliset vasta-aineet
Russian ANTITELA MONOKLONAL'NYE, MONOKLONAL'NYE ANTITELA, АНТИТЕЛА МОНОКЛОНАЛЬНЫЕ, МОНОКЛОНАЛЬНЫЕ АНТИТЕЛА
French Anticorps monoclonal, Anticorps monoclonaux
Croatian MONOKLONSKA PROTUTIJELA, PROTUTIJELA, MONOKLONSKA, ANTITIJELA, MONOKLONSKA
Czech monoklonální protilátky, protilátky monoklonální
Polish Przeciwciała monoklonalne
Japanese モノクローナル抗体, 抗体-モノクローナル, 単クローン性抗体, モノクロナール抗体, 単クローン抗体
Spanish anticuerpo monoclonal (sustancia), anticuerpo monoclonal, Anticuerpos Monoclonales
German Antikörper, monoklonale, Monoklonale Antikörper
Italian Anticorpi monoclonali
Portuguese Anticorpos Monoclonais

Ontology: Biological Agents (C2979985)

Definition (NCI) Biotechnology-derived pharmaceutical agents made from living organisms or their products. Includes recombinant proteins, monoclonal antibodies, and nucleic acids.
Definition (NCI_BRIDG) A substance made from living organisms or things they produce. EXAMPLE(S): virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, analogous product
Definition (NCI_CDISC) A substance made from living organisms or things they produce, for example: virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product.
Definition (NCI_NCI-GLOSS) A substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases. Biological agents include antibodies, interleukins, and vaccines.
Definition (CSP) protein, enzyme, metabolite, nucleic acid, microorganism etc that has therapeutic characteristics; originated as a biological product but may be engineered to produce optimal therapeutic value; may include synthetic mimics.
Definition (CSP) medicinal preparations made from living organisms or their products; venoms, enzymes may be indexed with this term; typically antibiotics and chemically pure biochemicals should not be indexed with this term, also narrower terms animal extract, plant extract, immunological substance or tissue/cell preparation should be considered.
Concepts Pharmacologic Substance (T121) , Biologically Active Substance (T123)
MSH D001688 , D001685
SnomedCT 373279003, 69509008, 115668003, 418980009
LNC MTHU047384, LP173689-3
English biological product, biotherapeutic agent, biological products, biological substance, agents biological, biopharmaceutical, biological substances, biopharmaceuticals, biologics, Biological Agents, Biologic Agents, Agents, Biological, Agents, Biologic, Biological product, Biological products, biological agent, Biologic, biological drug, BIOLOGIC, Biologic Agent, biologic agent, Biological agent (product), Biological agent, Biological substance (substance), Biological substance, Biological agent, NOS, Biological Products, Biologics, Biological Agent, Biologicals, Biopharmaceuticals, Biological agent (substance)
Spanish agente biológico (sustancia), substancia biológica, agente biológico (producto), agente biológico, sustancia biológica (sustancia), sustancia biológica
Swedish Biologiska produkter
Finnish Biologiset tuotteet
Japanese 生物学的製剤, 生物学的製薬, 生物製剤
Polish Substancje biologiczne, Środki biologiczne, Produkty naturalne
Latvian Not Translated[Biological Agents]

Ontology: Biosimilar Pharmaceuticals (C3178809)

Definition (MSH) BIOLOGIC PRODUCTS that are imitations but not exact replicas of innovator products.
Definition (MSHCZE) analoga originálních biologických léků
Concepts Pharmacologic Substance (T121)
MSH D059451
English Biosimilar Pharmaceuticals, Pharmaceuticals, Biosimilar, Biosimilar Pharmaceuticals [Chemical/Ingredient]
French Produits pharmaceutiques biosimilaires, Médicaments biosimilaires
Portuguese Medicamentos Biossimilares, Medicamentos Biogenéricos
Russian BIOPODOBNYE FARMATSEVTICHESKIE PREPARATY, БИОПОДОБНЫЕ ФАРМАЦЕВТИЧЕСКИЕ ПРЕПАРАТЫ
Spanish Biosimilares Farmacéuticos
Polish Leki biopodobne, Farmaceutyki biopodobne, Produkty biopodobne, Leki bionastępcze
Italian Farmaceutici biosimilari, Sostanze farmaceutiche biosimilari
German Biosimilar-Arzneimittel
Czech biosimilars, podobná biologická léčiva