Monoclonal antibody technology is viewed as the killer of tumor and tuberculosis, etc. because it can avoid specificity problem of antibody preparation, and can be manufactured to the highly uniform antibody which targets only a certain antigenic epitope, i.e., a “guided missile” with higher precision, and can conduct “directional striking” for specific disease.
Monoclonal antibody biological products are performing well in diagnosis and treatment of tumor, autoimmunity disease, cardiovascular disease and infectious disease nowadays. This variety of drug is widely used in clinics due to its strong specificity, obvious efficacy and low toxicity, etc., which is also the reason why it always ranks top in the global pharmaceutical product sales list.
Certainly global pharmaceutical giants will not let off this “gold mine” in the medical circle. Multinational pharmaceutical enterprises such as Roche, Abbott and Pfizer compete to invest heavily to seize the “highland”. Antibody drugs accounted for about 50% among the top ten drugs in global sales volume in 2012.
Chinese market has become the key highland for pharmaceutical enterprises to seize biological similar because of its huge consumption potential. There have been many pharmaceutical enterprises announcing their strategy decision on biological similar so far.
Whether they are multinational enterprises or Chinese enterprises, they shall consider how to adapt to Chinese regulations and guiding principles so as to seize Chinese biological similar market. Rules relevant to biological similar are now under one time window of trial and error and formulation. But how to grasp this window opportunity depends on the skills of each enterprise.
