Abstract
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 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. 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: bio?medicine, animal welfare and the most recent ad?vances in biotechnology. In particular, biopharmaceutical drug development is a challenging issue regarding treatment of rare diseases. Razvoj biofarmaceutika predstavlja izazov u bioetici. Za razliku od uobicajenih lekova male molekulske mase, biofarmaceutici su proteini kompleksne trodimenzionalne strukture koji se dobijaju tehnologijom rekombinantne DNK i tehnikom hibridoma. Imunogenost biofarmaceutika treba uvek proveriti u klinickim studijama zbog male prediktivne prednosti pretklinickih animalnih modela. Medjutim, primati i transgeni sojevi miseva mogu se upotrebiti da bi se naznacili neki aspekti imunogenosti. Znacajni napori su ucinjeni u cilju smanjenja upotrebe primata u razvoju biofarmaceutika, npr. poboljsanja dizajna istrazivanja i promene u zakonskoj regulativi. Osim toga, u ovoj oblasti su aktivne i pojedine ekspertske grupe. Uprkos tome, postoji rastuci trend upotrebe primata izuzev coveka u pretklinickom ispitivanju bezbednosti biofarmaceutika, posebno kada su u pitanju monoklonska antitela. Druga bioeticka pitanja koja se mogu dovesti u vezu sa razvojem biofarmaceutika su odnos njihove cene i efikasnosti, procena bezbednosti u klinickim uslovima, proizvodnja bioloski slicnih lekova i uporedjivanje njihove efikasnosti sa placebom u zemljama u kojima ne postoji namera o plasmanu. Upoznavanje humanog genoma otvorilo je mnoga bioeticka pitanja. Razvoj biofarmaceutika je vazno bioeticko pitanje iz vise razloga. Ono povezuje sve aspekte savremene bioetike: biomedicinu, dobrobit zivotinja i najnovija dostignuca u biotehnologiji. Posebno, razvoj biofarmaceutika je izazov kada je u pitanju lecenje retkih bolesti.