Biological medicines: Three decades of progress
Biološki lekovi: Tri decenije razvoja
Any medicine whose active substance is present in living organisms, or derived from living organisms, may be considered as a biological product. Vaccines, blood derivatives and products, or hormones isolated from animal or human tissues are produced by traditional biotechnological means and have a long history of use as biologies. With introduction of the recombinant human insulin in 1982, there started an era of 'high-tech' biological medicines, also known as biopharmaceuticals. Recombinant proteins, produced by recombinant DNA technology, and monoclonal antibodies, whose development was based on hybridoma technology, comprise the majority of biopharmaceuticals. The necessity of using biological methods for full characterization is considered by the drug regulation authorities as the key property of biologies, related to complexity and heterogeneity of their structure. Hence, classification of a product as a biological can change over time. For example, the full characterization of an...tibiotics by physical and chemical methods is feasible nowadays, and hence these drugs are not regarded as biologies any more. Paradoxically, it is possible that a synthetic product be regarded as a biological medicine, and this is the case with pegaptanib, a pegylated modified oligonucleotide, classified into biopharmaceuticals. Hence, the need of introducing a category of borderline products into classification of medicines is noticeable; these products possess some properties of conventional chemical medicines, in addition to those of biologies.
Keywords:Biological methods / Biopharmaceuticals / Biotechnological medicines
Source:Arhiv za farmaciju, 2012, 62, 4, 352-363
- Savez farmaceutskih udruženja Srbije, Beograd