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Biobetters in Key Markets - Opportunities for Biotechnology Companies to Sustain Innovation with Low Risk and High Value Offerings
Date:11/15/2012

? 153.1.4 Insulin and Insulin Analogs 163.1.5 Monoclonal Antibodies 193.1.6 TNF-? Inhibitors 203.2 Promising Drug Classes for Biobetter Therapies 213.2.1 Human Growth Hormone 213.3 Comparison of Biosimilars and Biobetters 234 Technology Analysis 264.1 Introduction 264.1.1 Host Cell 264.1.2 Glycosylation 274.1.3 PEGylation 284.1.4 Polysialylation 284.1.5 Fusion Protein 284.1.6 PASylation 284.1.7 HESylation 295 Challenges and Opportunities 305.1 Opportunities 305.1.1 Biobetter Therapies Gain Substantial Market Shares upon Launch 305.1.2 Higher Success Rates in the Development of Biobetter Therapies 305.2 Challenges 305.2.1 Uncertainty Surrounding the Implementation of the Affordable Care Act will Limit Patient Access to Biobetter Drugs 305.2.2 Growing Debts and the Slowing of the Economy will Drive Governmental Bodies and Healthcare Providers to Restrict the Use of Expensive Biobetter Therapies 315.2.3 Regulatory Policies in Emerging Economies such as China and India do not Provide Enough Protection for the Development of Biobetter Therapies 316 Pipeline Analysis 326.1 Introduction3 326.2 Human Growth Hormone 326.3 Erythropoietin 346.4 Granulocyte-colony Stimulating Factor 356.5 Interferon-? and Interferon-? 366.6 Insulin and Insulin Analogs 386.7 Monoclonal Antibodies 406.8 Promising Drugs 426.8.1 LB03002 - HGH 426.8.2 Degludec - Insulin Analog 426.8.3 Theracim - Monoclonal Antibody 436.8.4 Pertuzumab - Monoclonal Antibody 436.8.5 RG7159 - Monoclonal Antibody 447 The US Regulatory Environment and Approval Pathways 457.1 Introduction 457.2 Biobetter Therapies 457.3 Biosimilar Therapies 468 The EU Regulatory Environment and Approval Pathways 478.1 Introduction 478.2 Biobetter Therapies 478.3 Biosimilar Therapies 479 Japan Regulatory Environment and Approval Pathways 499.1 Biobetter Therapies 499.2 Biosimilar Therapies 5010 Australia Regulatory Environment and Approval Pathways 5110.1 Biobetter Therapies 5110.2 Biosimilar Therapies 5111 China Regulatory Environment and
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