BCPIA - What does BCPIA stand for? The Free Dictionary
References in periodicals archive
creates a new category of approval - a 351(k) - for biosimilars under the Public Health Service Act (PHS).
85 The Development of a US Biosimilar Pathway 87 The BCPIA
89 Approval will be no guarantee of interchangeability 90 Biosimilar market exclusivity 90 Reference product data exclusivity 90 White House seeks to lower data exclusivity period 91 Patent dispute resolution 91 User fees 93 Implementation of the BCPIA
95 Slow progress in 2011 98 The Regulatory Situation in Europe 100 Regulation of biosimilars 101 EMA Guideline Documents 102 Regulation of Monoclonal Antibodies 104 Regulations in Other Developed Markets 105 Australia 105 Canada 105 Japan 105 Singapore 106 Regulations in Developing markets 107 Why are these markets worth a look?