Journal of Pharmacovigilance

Nikhil Pai

Publications

• Review Article
  Pharmacovigilance of Oncology Biosimilars
  Author(s): Luis H. Camacho and Nikhil PaiLuis H. Camacho and Nikhil Pai
  
  Biologicals are critical in cancer medicine. Four of the top ten biological blockbusters worldwide are oncology drugs used for therapeutic or supportive care. The global market for biologic cancer therapies approximately totalled US$ 51.2 billion in 2014 and is expected to reach US$ 66.4 billion in 2019. The patents of most of these top-selling agents will expire by the year 2020 attracting industry to develop biosimilars - agents with high similarity to their biological reference product. Furthermore, manufacturing biosimilars is more cost and time effective than developing their reference products. The cost containments derived from the biosimilars entry to the market are expected to result in considerable societal savings and financial relief to health systems globally. Led by the European Medicines Agency, and the Food and Drug Administration, sev.. View More»
  DOI: 10.4172/2329-6887.S3-001

  Abstract PDF