//fpnotebook.com/
Biological Agent
Aka: Biological Agent, Monoclonal Antibody, Biosimilar Pharmaceuticals, Biosimilars
- See Also
- Immunoglobulin
- Monoclonal Antibody-Mediated Chemotherapy
- Janus Kinase Inhibitor
- Definitions
- Biologic Agents
- Pharmaceutical preparations manufactured within biologic systems (e.g. microorganisms)
- Contrast with classical drugs that are chemically synthesized
- Biosimilars
- Biologic agents that are similar to the original or reference biologic agent, but not exact duplicates
- Manufacturers of Biosimilars are not required to show FDA similar efficacy to reference agents
- Biosimilars tend to cost up to one third less of the original reference agents
- Examples
- Neupogen (filgrastim) has 2 Biosimilars (Nivestym, Zarxio)
- Remicade (Infliximab) has 2 Biosimilars (Inflectra, Renflexis)
- Neulasta (pegfilgrastim) has the biosimilar Fulphila
- Types: Biologic Drug Name Interpretations
- Biologic Agent naming conventions have changed over time
- Transitioning from an older source system naming (e.g. Xi), to a target system naming (e.g. fung)
- Older example: Tras-tu-zu-mab (anti-tumor, humanized mononclonal Antibody)
- Newer example: benra-li-zu-mab (immune-targeted, humanized Monoclonal Antibody)
- Suffix
- Mab: Monoclonal Antibody
- Cept: Protein that mimics an Immunoglobulin
- Pre-Suffix
- U: All human origin
- O: Mouse cell origin
- Zu: Humanized origin
- Xi: Mixed or chimeric (part human and part non-human origin)
- Middle, Bridging Syllable
- T: Tumor target
- So: Bone target
- Ci: Circulation target
- Gro: Growth factor target
- Ba: Bacterial target
- Fu: Fungal target
- Vi: Virus
- Ki: Interleukin target
- Li: Immune target
- Toxa: Toxin target
- References
- Nomenclature of monoclonal antibodies (Wikipedia)
- https://en.wikipedia.org/wiki/Nomenclature_of_monoclonal_antibodies
- Types: Monoclonal Antibody
- Identical antibodies that are synthesized by a single immune cell type
- Synthesized in labs to be targeted at disease-specific molecules
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Inflammatory Bowel Disease (Crohn's Disease, Ulcerative Colitis)
- Targeted Cancer Therapy
- Monoclonal Antibody-Mediated Chemotherapy
- Small Molecule Inhibitor-Mediated Chemotherapy
- Adverse Effects
- Most targeted biologic agents (e.g. monoclonal antibodies) have the potential for serious adverse effects
- Adverse effects fall in general patterns, but each agent also may have specific side effects
- Infectious disease
- Live Vaccines are contraindicated
- Decreased cellular Immunity
- Tuberculosis
- Sepsis
- Systemic fungal infection
- Hepatitis B activation
- Progressive Multifocal Leukoencephalopathy or PML (polyoma virus)
- Disseminated Herpes Zoster
- Neurologic syndromes
- Multiple Sclerosis
- Seizures
- Guillain Barre
- Hematologic Effects
- Aplastic Anemia or other Pancytopenia
- Malignancy
- Non-Melanoma Skin Cancer
- Lymphoma
- Miscellaneous
- Pneumonitis
- Thyroid disease
- References
- Swadron and Mallon in Herbert (2018) EM:Rap 18(11): 7-8