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Global Biosimilars: A return to optimism?
Date:12/12/2012

ck & Co (formerly Schering-Plough) Interferon A (Intron A range) 50
Betaseron/Betaferon 51
Avonex 51
Rebif 52
Current Biosimilar Activity 53
USA 53
European Union 53
Rest of the World 53
Beyond the First wave 55
Etanercept 56
Amgen gains new patent for etanercept 56
Summary sales data – Amgen (USA & Canada) 57
Summary sales data – Pfizer (Outside USA & Canada) 57
Current Biosimilar activity 58
Monoclonal Antibodies 59
Adalimumab 62
Summary sales data 62
Current Biosimilar activity 63
Bevacizumab 64
Summary sales data 64
Current Biosimilar activity 64
Cetuximab 65
Summary sales data 65
Current Biosimilar activity 66
Infliximab 67
Summary sales data 67
Current Biosimilar activity 67
Rituximab 68
Summary sales data 68
Current Biosimilar activity 69
Dr Reddy's: Reditux 69
Trastuzumab 70
Summary sales data 70
Current Biosimilar activity 70
WHY Are biosimilars an issue now? 71
Rising cost of healthcare 71
Is there a commercially viable market? 72
The price reduction of the biosimilar 72
Case Study: Biosimilar prices in the UK 73
Omnitrope 73
G-CSF 74
EPO 74
Patient population 75
Physician & patient acceptance 76
Regulatory attitude 77
National pricing & reimbursement policies 78
Interchangeability and substitutability 78
Norway makes biosimilar G-CSF switchable – then changes its mind 79
Extent of existing competition 80
Originator strategies to counter biosimilars 81
Global market size estimates, 2015 82
The Regulatory Situation in the USA 83
Overview of the US regulatory system 83
Hatch-Waxman is not generally applicable to biologics 84
The 505(b)(2) route 84
Enoxaparin 84
Another option: file a full BLA? 85
The Development of a US Biosimilar Pathway 87
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