Abstract
Some chronic systemic diseases, including diabetes mellitus, require the life-long use of biotechnological medical products, of which quality,effectiveness and safety depends the duration and quality of life for patients.Patent protection expiry of many original biological agents has assumed the key role in development of biosimilars (replica versions of originalbiotechnological products) and their broad entrance to the pharmaceutical market. Because of structural complexity of biological products andimpossibility of precise reproduction of patented processing, biosimilars are not ideal duplicates of original substances. Despite numerous evidence oftherapeutic nonequivalence, danger of mechanical substitution of original agents still exists in Russia due to lower price of biosimilars - and lackof legislative acts, regulating registration and circulation of such drugs.In this article we characterize biosimilars in great detail and review major problems of their use, that is: aspects of quality control; disparity withoriginal bio-agents in efficacy and safety; clinical trial requirements, registration procedures and subsequent safety control.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
