Filozofija i drustvo 2012 Volume 23, Issue 4, Pages: 49-56
https://doi.org/10.2298/FID1204049T
Full text ( 269 KB)
Bioethical issues in the development of biopharmaceuticals
Todorović Zoran (Faculty of Medicine, Department of Pharmacology, Clinical Pharmacology & Toxicology, Belgrade)
Protić Dragana (Faculty of Medicine, Department of Pharmacology, Clinical Pharmacology & Toxicology, Belgrade)
Development of biopharmaceuticals is a challenging issue in bioethics. Unlike
conventional, small molecular weight drugs, biopharmaceuticals are proteins
derived from DNA technology and hybrid techniques with complex three
dimensional structures. Immunogenicity of biopharmaceuticals should always be
tested in clinical settings due to low predictive value of preclinical animal
models. However, non-human primates (NHP) and transgenic mice could be used
to address certain aspects of immunogenicity. Substantial efforts have been
made to reduce NHP use in biopharmaceutical drug development, e.g. study
design improvements and changes in regulatory policy. In addition, several
expert groups are active in this field (e.g. NC3Rs, BioSafe, and
Biopharmaceutical Technical Group). Despite that, there is an increasing
trend of use of NHP in preclinical safety testing of biopharmaceuticals,
especially regarding monoclonal antibodies. Other potential bioethical
issues related biopharmaceutical drug development are their
cost/effectiveness ratio, clinical safety assessment, production of
biosimilars, and comparison of their efficacy with placebo in countries
without intention to market. Identification of the human genome has opened
many new bioethical issues. Development of biopharmaceuticals is an important
bioethical issue for several reasons. It connects all aspects of contemporary
bioethics: biomedicine (e.g. clinical trials in vulnerable subjects), animal
welfare and the most recent advances in biotechnology. In particular,
biopharmaceutical drug development is a challenging issue regarding treatment
of rare diseases.
Keywords: bioethics, biopharmaceutics, drug development, immunogenicity, animal welfare, non-human primates