Lecture on Biologics and Biosimilars by Prof. Dr. Joachim W. Herzig

One important aspect of National University of Medical Sciences’ (NUMS) mission and vision is to introduce innovation into medicines through research and latest technologies. Keeping this in view, Office of Research, Innovation and Commercialization (ORIC) invited Prof. Dr. Joachim W. Herzig (Ph.D., D.Sc.) from Johannes Gutenberg University, Germany to share his expertise on Biologics and Biosimilars.

The speaker started the session with overview of the topic. Afterwards, he thoroughly explained the phenomena of Biologics, Biosimilars, and Biologic Drugs. The physiological mechanism of biologic drugs was also elucidated. Dr. Herzig also discussed presumed complexities in manufacturing Biologics. The speaker stressed that Biologic medicines cannot be duplicated since they are highly complex molecules. Dr. Herzig provided a glimpse of revolution that

Biologics could introduce into healthcare and treatment of diseases, disorders and conditions.

Dr. Herzig stressed that Biosimilars are similar to the reference biologic product but not exactly the same. Legislations and patient safety regulations pertaining use, test and prescription of Biosimilars and Biologics were also discussed. Technicalities, legal complications, administrative procedures of producing Biologics, Biosimilars and Biobetters, specifically in the context of Pakistan were thoroughly explored. The speaker argued that mass production of Biologic drugs will result in reduced price of the product for the end user. Proposition of substituting Biologics with Biosimilars was also highlighted.    

The speaker thoroughly entertained all the questions of the participants. Current research proceedings in Biologics and Biosimilars in the context of Pakistan were also discussed. The next presentation included variety of topics from Pharmacokinetics i.e. bioequivalence, absolute and relative bioavailability. These topics were explained by using cases, graphs and numerical data. The criteria, guidelines and legal formalities of Food & Drug Administration (FDA) of USA and European Medicine Agency (EMA) regarding bioequivalence testing were also delineated at the end of the presentation. An interactive session was held after the presentation in which all the researchers, faculty and other participants cleared their ambiguities about the topic through discussion.

The Vice Chancellor, Pro Vice Chancellor, Dean Research and Director research discussed the possibilities of establishment of the institute of Biotechnology and to train the master trainers in recent developments in clinical trials, bioavailability, bioequivalence and drug development in the new building of NUMS, with Dr. Herzig. In the end, VC NUMS, Lt. Gen. Syed Muhammad Imran Majeed presented the souvenir to Dr. Herzig.