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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:
Bacteria
l 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 Vaccine
s 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
Seizure
s
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
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