title: Monoclonal antibody: the corner stone of modern biotherapeutics.
abstract: Worldwide sales of biologic drugs exceeded 100 billion USD in 2011. About 32% is from therapeutic monoclonal antibody (mAb). With many blockbuster biopharmaceutical patents expiring over the next decade, there is a great opportunity for biosimilar to enter the worldwide especially emerging market. Both European Medicines Agency (EMA) and Food and Drug Administration (FDA) have introduced regulatory frameworks for the potential approval of biosimilar mAb therapeutics. Rather than providing a highly abbreviated path, as in the case for small molecule chemical drug, approval for biosimilar mAb will require clinical trial and the details will be very much on a case-by-case basis. Since mAb is the dominant category of biologic drugs, mAb will be the focus of this review. First, the United States (US) and European Union (EU) approved mAb and those in phase 3 trials will be reviewed, then strategies on how to win biosimilar competition will be reviewed.
authors.affiliation: R&D Synageva Biopharma Corporation, Lexington, MA 02421, USA. xia8894@yahoo.com
authors.forename: Zhi-nan
authors.initials: ZN
authors.lastname: Xia
authors.forename: Xue-ting
authors.initials: XT
authors.lastname: Cai
authors.forename: Peng
authors.initials: P
authors.lastname: Cao
mesh_terms: D000818:Animals; D018033:Antibodies, Bispecific / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000592:standards*; D017326:Clinical Trials, Phase III as Topic; D017277:Drug Approval; D005062:European Union; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018033:Antibodies, Bispecific; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D059451:Biosimilar Pharmaceuticals