Overview of Regulatory Approval Process in EU and US for Bio-generics

Abstract: Biologics are therapeutic agents or their analogs, mostly consisting of proteins and other products (monoclonal antibodies and hormones) derived from living organisms for the treatment or management of diseases or injuries1. Bio-generics are the same as innovator biologics but are approved only after pioneer has developed the original version. Biotechnology produces biotherapeutic agents on industrial scale. These agents include both novel agents and agents formerly available in small quantities. The bio-generic market is the upcoming field and it is developing rapidly. As the EU and the US are highly regulated markets and laws are very much clear for the application, still there is chance of rejection. In this paper, author has tried to give the overview for application of bio-generic in these highly regulated markets.

Bio Generics - The Future

Bio-generics are generic form of biologics (therapeutics agents or analogs, mostly consisting of protein and other products derived from living organisms). Bio-generics are called as “Follow on protein products” in U.S. and “Similar biological medicinal products” in E.U. It is a new word in the pharmaceutical market and may create revolution in the next couple of years as many biologics are going off patent by 2006. Global non-biogenerics market is highly saturated due to large number of players and few blockbusters. Moreover, blockbuster drugs cannot be sustained for too long in the present scenario. In this situation, pharmaceutical companies cannot afford to ignore bio-generics, as they comprises source of new potential molecules capable of acting upon specific targets and present an attractive solution to solve production crisis.

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