药学学报, 2012, 47(10): 1275-1280
引用本文:
XIA Zhi-nan, CAI Xue-ting, CAO Peng. Monoclonal antibody: the corner stone of modern biotherapeutics[J]. 药学学报, 2012, 47(10): 1275-1280.
XIA Zhi-nan, CAI Xue-ting, CAO Peng. Monoclonal antibody: the corner stone of modern biotherapeutics[J]. Acta Pharmaceutica Sinica, 2012, 47(10): 1275-1280.

Monoclonal antibody: the corner stone of modern biotherapeutics
XIA Zhi-nan1*, CAI Xue-ting2, CAO Peng2
(1. R&D Synageva Biopharma Corporation, Lexington MA 02421, USA; 2. Laboratory of Cellular and Molecular Biology, Jiangsu Province Institute of Traditional Chinese Medicine, Nanjing 210028, China)
摘要:

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.

关键词:   
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.

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