Date:12/12/2012

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? 107
Brazil 108
India 109
Indonesia 110
Mexico111
Saudi Arabia 112
Thailand 112
Vietnam 112
Who will be the players in the market? 113
Current Market Leaders 116
Sandoz 116
Omnitrope 116
Binocrit 116
Zarzio 116
Rituximab 116
Agreements 117
Sandoz' Biosimilar Sales 117
Teva Pharmaceutical Industries 118
Tevagrastim/Neutroval 118
Rituximab 118
Teva's Biosimilar Sales 119
Hospira 120
Retacrit120
Nivestim 121
Distribution deal with Celltrion 121
Pliva sells biosimilar rights and facility to Hospira 121
The Indian Biosimilar Industry 122
Avesthagen 122
AVDESP 122
Avent 122
Kemwell Biopharma 123
BiotechCorp 123
Siegfried Biologics 123
Intas Pharmaceuticals 123
Biocon 124
Basalog 124
Insugen 124
Erypro 125
NUFIL125
Other products 125
Pfizer and Biocon announce major insulin deal 125
Biocon takes 100% control of JV from CIMAB 125
Mylan and Biocon announce biosimilar deal 126
Biocon buys majority stake in German marketing company 126
Cipla 127
Mab Pharma/Bio Mabs 127
Claris Lifesciences 128
Dr Reddy's 129
Gennova Biopharmaceuticals 130
Intas Biopharmaceu
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