Journal of Bioequivalence & Bioavailability

Biosimilars: Latin America s coming on board regulatory approval and market access

7^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit

August 29-31, 2016 Atlanta, USA

Marlene Llopiz-Aviles

Harvard University School of Public Health, USA

Posters & Accepted Abstracts: J Bioequiv Availab

Abstract:

Biotechnological medicines are medicinal products of biotechnological origin that contain proteins derived from DNA technology. The biotechnologies use living organisms such as plant and animal cells, bacteria, viruses and yeasts for the production of medicines that includes such biological factors as cytokines, hormones, clotting factors, monoclonal antibodies, vaccines, etc. Biosimilars are attempted copies of existing biological medicinal products or protein drugs. They are made with a different cell line and a different manufacturing and purification process. Biosimilars are coming after the expiry of patent protection for many original medicines. They are considered as possible products at lower costs in comparison to modern therapies for patients and governments which are often more acceptable by patients. Less time and money is spent on clinical research for them to reach the market, as well as less pharmacovigilance. The experience with biosimilars to date is limited and long term safety and efficacy are unavailable. Immunogenicity is often unknown. Because of the above, there is need for appropriate regulations, the clear identification of potential problems and close pharmacovigilance. Latin America has become a new marketplace for the commercialization of biosimilars. However, the lack of regulations, requiring strict clinical trials and close pharmacovigilance has created Latin America an easy target for local and foreign companies to market biosimilars. As in all countries, significant clinical and non-clinical testing should be required for biosimilars to be marketed in Latin America. Substantial NDA-type dossiers should be submitted and postmarket safety surveillance must be carried out. For that to occur, substantial manufacturing investments and sales promotion and marketing are required to be set in place. Latin America can certainly become a safe marketplace for biosimilars only and now that regulatory strategies are set in place and clinical and non-clinical trials are conducted with detailed pharmacovigilance before and after their marketing. The objectives of this study are: To make companies in Europe and worldwide aware that Latin America is setting down clear regulations on biosimilars; for Latin America to follow the EMA guidelines on biosimilars; and for the worldwide standardization of guidelines on biosimilars.