BIOLOGICS AND BIOSIMILARS- A MEDICINE FROM THE LIFE AND FOR THE LIFE: THE COMPLETE REVIEW

In this review, we are completely discussing different eras in pharmaceutical drugs/medicines, i.e., Biologics and biosimilars. These biologics can be called life drugs because they are deriving from living organisms, microbes, yeast, bacteria, and human blood products. These biologics are biopharmaceutical products that are derived from living organisms and are very complex in molecular structure, and do have very high molecular weight. The synthesis of these biologics is completely different from the small molecule drugs that are chemically synthesized. These biologics are synthesized by recombinant DNA technology. As these biologics are patented, they won’t allow the copying of these products. But they are now expiring their patents and leading their way to the development of their close copies, i.e., Biosimilars. Biosimilars are the copies of the biological which has to be proven as highly similar to that of their branded biologics for their efficacy and safety and has to be developed after the expiring of the patent term period of the biologics, like the generic drugs for the branded pharmaceutical drugs. This biologics development costs around >$1Billion and the development of biosimilars costs around $100-200M. Highly similarity of biosimilars to that of their biologics can be determined by the “totality of evidence”, which may involve 2-300 analytical tests for the assessment of similarity of biosimilars to the biologics. The approval of these involves the various regulatory authorities and Acts like • European Medicine Agency, Europe • Pathway of Biosimilars Act, 2009, the USA, etc.