Examples of Biologicals Used in Medicine
Biologicals are substances derived from living organisms or their products, including antibiotics, antibodies, anti-virals, immunomodulators, nucleic acids, and vaccines, which are used to treat various medical conditions. 1
Types of Biologicals
Antibodies and Proteins
- Monoclonal antibodies (such as adalimumab) are used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis 2, 3
- Antibodies target specific cytokines or receptors in the immune system to reduce inflammation and modify disease progression 3, 4
- Fusion proteins combine parts of different proteins to create targeted therapeutic effects 3
Vaccines
- Vaccines are available for the prevention of anthrax, cholera, plague, Q fever, and smallpox 1
- No licensed vaccines are currently available for botulinum toxins, viral encephalitis, melioidosis, or ricin 1
Anti-infective Biologicals
- Antibiotics remain the mainstay treatment following exposure to anthrax, plague, Q fever, and melioidosis 1
- Anti-toxin therapy is used for botulinum toxins 1
- Anti-virals are used for smallpox and other viral infections 1
Immunomodulators
- Biologicals that modify immune responses are used in treating autoimmune disorders 3, 5
- These include agents targeting IgE, T helper 2 (Th2)-type cytokines (IL-4, IL-5, IL-9, IL-13, IL-31), and pro-inflammatory cytokines (IL-1β, IL-12, IL-17A, IL-17F, IL-23, TNF) 5
Applications in Medicine
Autoimmune Disorders
- Biologicals have revolutionized the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriasis, and inflammatory bowel disease 3, 5
- TNF inhibitors like adalimumab are used for multiple inflammatory conditions 2, 3
Cancer Treatment
- Biologicals are widely used in treating HER2-positive breast cancer, leukemias, lymphomas, and colorectal and lung cancers 3
- They can target specific cancer cells while sparing healthy tissue 3, 4
Other Medical Applications
- Erythropoietin for renal failure-associated anemia 3
- PCSK9 inhibitors for patients with elevated LDL levels despite statin treatment 3
- Biologicals for allergic disorders targeting specific immune pathways 6, 5
Biosimilars
Definition and Development
- Biosimilars are biological products highly similar to an already-approved biological product (bio-originator) 1
- They are not generic equivalents due to the complexity of biological molecules 1, 7
- Manufacturing processes significantly impact the properties of biologicals 1
Regulatory Considerations
- Regulatory approval requires extensive analytical studies and clinical trials comparing pharmacokinetics, pharmacodynamics, immunogenicity, efficacy, and safety 1
- The EMA established a specific legal pathway for biosimilar authorization in 2005, followed by the US FDA in 2010 1
- Traceability is important for pharmacovigilance, requiring distinguishable naming conventions 1
Clinical Implications
- Biosimilars can increase access to biological therapies by reducing costs 1
- An approved biosimilar should provide patients with an equivalent biological product at a lower cost 1
- Healthcare providers should be informed about biosimilars to address misconceptions about their quality and efficacy 1
Safety Considerations
- Biologicals can potentially cause hypersensitivity reactions during first exposure or after repeated exposures 6
- Monitoring for immunogenicity is essential as biologicals can trigger immune responses 6
- Serious infections and malignancies are potential risks with certain biologicals like TNF inhibitors 2
By understanding the various types and applications of biologicals, healthcare providers can better utilize these powerful therapeutic agents to improve patient outcomes across multiple disease states.