Journal of Bioequivalence & Bioavailability

Addressing biosimilars: A future perspective

3^rd World Congress Bioavailability & Bioequivalence

March 26-28, 2012 Marriott Hotel & Convention Centre, Hyderabad, India

Sumit Kumar Jain, N.Siva Prasad and Pallab de

Posters: J Bioequiv Availab

Abstract:

B iopharmaceuticals represent a fast-growing and important class of drugs for the treatment of various severe diseases like growth disorders, acute myocardial infraction, leukemia, neutropenia, ischemic events etc. ?Biosimilars? (in Europe) or ?follow-on biologic? (in US) are basically protein molecules which are similar, but not identical to, an existing available approved product. In contrast to available generic drug, it is next to impossible to create copycat of a biological drug because of intricate nature of biological (protein) molecules. Research also suggests that because of inactivation by the body?s normal immune response, protein molecules lose their efficacy when used for longer duration or may provide a more rapid immune response than original drug; thereby results serious side effects in patients. In ad dition, biosimilars have enormous regulatory issues as they are not considered to be generic drugs. In contrast to generic drugs, there is no adequate guidance available for the approval of biosimilars in regulated market which in turn provide additional advantage to innovator to survive in the market for longer period. Compare to US regulations where there are lack of legislation for formal approval process, Europe has more conspicuous guidance on biosimilars. Based upon above scenario there is huge expectation of industries from regulatory bodies to provide formal guidance which reduce healthcare expenditure, increase access of biological drugs to patients by considering their safety and encourage development of affordable and quality biosimilars. By keeping above mentioned scenario in mind, authors have made an attempt to discuss following issues related to biosimilars: safety, need for clinical trials and indication specific approval, product identifiability and traceability, post-marketing risk management plans required, automatic substitution, nam ing and labeling/ prescription rules and how biosimilars should be evaluated by regulators, pharmacist, physicians and patients.