Abstract

Biopharmaceuticals and their generic counterparts referred to as biosimilars represent the fastest growing segment of the pharmaceutical market. In contrast to conventional small molecule therapeutics, myriad additional considerations need to be addressed during the regulatory approval process. Key issues surrounding these protein based agents stem from their biosynthesis from living cells, and include post translational modification, propensity to aggregate, and variation in three dimensional structure. Though existing regulatory pathways in the USA have successfully managed the approval of a number of blockbuster biopharmaceuticals, they did not specifically address generic versions of these agents. Given the importance of this class, the US FDA recently followed suit with other global regulatory agencies and issued guidelines for their introduction and approval. As the market for biosimilars is set to grow rapidly and the technology for their production is continually evolving, herein we review the state of the art in 2012 for their production, and likely areas for growth and innovation in the sector.

Keywords: Biogenerics, biosimilars, biotechnology, cell lines, FDA, glycosylation, monoclonal antibodies, post translational modification, protein expression, regulatory science, biopharmaceuticals, monoclonal antibody technologies, generic competition, hypersensitivity, pseudo-allergic/anaphylactoid.