Back to Report Store Home

Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment

  • Published: Apr-2011
  • Report Code: GBIHC075MR
  • Report Format: pdf

Description

List of Figures

Figure 1: Biosimilars Approval Pathways in the US and Europe, Global Biologics Market Forecast, ($bn), 2009–2016

Figure 2: Biosimilars Approval Pathways in the US and Europe, Share of Top 25 Biologics By Therapeutic Class, 2009

Figure 3: Biosimilars Approval Pathways in the US and Europe, Growth for Biologics, 2010

Figure 4: Biosimilars Approval Pathways in the US and Europe, Share of Top 25 Biologics By Production System, 2008

Figure 5: Biosimilars Approval Pathways in the US and Europe, Biologics Under Development by Therapeutic Class, Global, 2008

Figure 6: Biosimilars Approval Pathways in the US and Europe, Biologics Under Development by Disease Category, Global, 2008

Figure 7: Biosimilars Approval Pathways in the US and Europe, Comparison of Small Molecule Drugs and Biologics

Figure 8: Biosimilars Approval Pathways in the US and Europe, Difference Between the Distribution Chains for Small Molecule and Biologic Drugs

Figure 9: Biosimilars Approval Pathways in the US and Europe, Medicare Coverage for Biologic Drugs, 2009

Figure 10: Biosimilars Approval Pathways in the US and Europe, Imminent Biosimilar Opportunities, 2010

Figure 11: Biosimilars Approval Pathways in the US and Europe, Comparison of Biosimilars With Generics, 2010

Figure 12: Biosimilars Approval Pathways in the US and Europe, Development Costs and Timelines for a Biosimilar, 2010

Figure 13: Biosimilars Approval Pathways in the US and Europe, Challenges and their Solutions in Biopharmaceutical Manufacturing, 2010

Figure 14: Biosimilars Approval Pathways in the US and Europe, Global, Market Forecasts, ($m), 2009–2016

Figure 15: Biosimilars Approval Pathways in the US and Europe, the US, Market Forecasts, ($m), 2009–2016

Figure 16: Biosimilars Approval Pathways in the US and Europe, Europe, Market Forecasts, ($m), 2009–2016

Figure 17: Biosimilars Approval Pathways in the US and Europe, Japan, Market Forecasts, ($m), 2009–2016

Figure 18: Biosimilars Approval Pathways in the US and Europe, Global, hGH Biosimilars Market Forecasts, ($m), 2009–2016

Figure 19: Biosimilars Approval Pathways in the US and Europe, Global, EPO Biosimilars Market Forecasts, ($m), 2009–2016

Figure 20: Biosimilars Approval Pathways in the US and Europe, Global, G-CSF Biosimilars Market Forecasts, ($m), 2009–2016

Figure 21: Biosimilars Approval Pathways in the US and Europe, Global, Interferon alfa Biosimilar Market Opportunity Analysis, ($m), 2009–2016

Figure 22: Biosimilars Approval Pathways in the US and Europe, Global, Interferon beta Biosimilar Market Opportunity Analysis, ($m), 2009–2016

Figure 23: Biosimilars Approval Pathways in the US and Europe, Global, Insulin and Insulin Analogs Biosimilar Market Opportunity Analysis, ($m), 2009–2016

Figure 24: Biosimilars Approval Pathways in the US and Europe, Global, TNF alfa Inhibitor Biosimilar Market Opportunity Analysis,($m), 2009–2016

Figure 25: Biosimilars Approval Pathways in the US and Europe, Global, Monoclonal Antibodies Against Cancer Biosimilar Market Opportunity Analysis, ($m), 2009–2016

Figure 26: Biosimilars Approval Pathways in the US and Europe, Global, Expected Market Split in 2016

Figure 27: Biosimilars Approval Pathways in the US and Europe, Key Success Factors in the Biosimilar Industry, 2010

Figure 28: Biosimilars Approval Pathways in the US and Europe, Comparison of Capabilities of Market Entrants, 2010

Figure 29: Biosimilars Approval Pathways in the US and Europe, Drivers and Restraints, 2010

Figure 30: Biosimilars Approval Pathways in the US and Europe, Rising Expenditure on Pharmaceuticals, 2010

Figure 31: Biosimilars Approval Pathways in the US and Europe, Increase in Elderly Population Indicates Rising Healthcare Expenses, 2010

Figure 32: Biosimilars Approval Pathways in the US and Europe, Inflation in Prescription Drug Prices in the US , 2010

Figure 33: Biosimilars Approval Pathways in the US and Europe, Costs of Development, Manufacturing and Approval of Biosimilars by Cell Culture Type, ($m), 2010

Figure 34: Biosimilars Approval Pathways in the US and Europe, Objectives of Biosimilar Legislation and Regulatory Frameworks, 2010

Figure 35: Biosimilars Approval Pathways in the US and Europe, the US, Regulatory Bodies for Biologics, 2010

Figure 36: Biosimilars Approval Pathways in the US and Europe, Drug Development and Approval Process, 2010

Figure 37: Biosimilars Approval Pathways in the US and Europe, the US, Evolution of Regulatory Pathway, 2010

Figure 38: Biosimilars Approval Pathways in the US and Europe, the US, Impact of Data Exclusivity Period on Biosimilars Development, 2010

Figure 39: Biosimilars Approval Pathways in the US and Europe, the US, Patent Litigation Provisions in BPCIA – Round 1, 2010

Figure 40: Biosimilars Approval Pathways in the US and Europe, the US, Patent Litigation Provisions in BPCIA – Round 2, 2010

Figure 41: Biosimilars Approval Pathways in the US and Europe, Key Issues Discussed at FDA’s Public Hearing on Biosimilars, 2010

Figure 42: Biosimilars Approval Pathways in the US and Europe, the US, Drivers and Barriers for the Biosimilars Market, 2009–2016

Figure 43: Biosimilars Approval Pathways in the US and Europe, Europe, Drug Approval Process, 2010

Figure 44: Biosimilars Approval Pathways in the US and Europe, Europe, Evolution of Regulatory Pathway for Approval of Biosimilars, 2010

Figure 45: Biosimilars Approval Pathways in the US and Europe, Europe, General and Product Specific Guidelines for Biosimilars, 2010

Figure 46: Biosimilars Approval Pathways in the US and Europe, Europe, Approval Process for Biosimilars, 2010

Figure 47: Biosimilars Approval Pathways in the US and Europe, Europe, Data and Market Exclusivity Periods, 2010

Figure 48: Biosimilars Approval Pathways in the US and Europe, Europe, Comparability Exercises, 2010

Figure 49: Biosimilars Approval Pathways in the US and Europe, Europe, Number of Biosimilar Applications, 2004–2009

Figure 50: Biosimilars Approval Pathways in the US and Europe, Europe, Key Issues Facing Biosimilars Market, 2010

Figure 51: Biosimilars Approval Pathways in the US and Europe, Europe, Drivers and Barriers for the Biosimilars Market, 2009–2016

Figure 52: Biosimilars Approval Pathways in the US and Europe, the UK, Drivers and Barriers for the Biosimilars Market, 2009–2016

Figure 53: Biosimilars Approval Pathways in the US and Europe, Germany, Drivers and Barriers for the Biosimilars Market, 2009–2016

Figure 54: Biosimilars Approval Pathways in the US and Europe, France, Drivers and Barriers for the Biosimilars Market, 2009–2016

Figure 55: Biosimilars Approval Pathways in the US and Europe, Spain, Drivers and Barriers for the Biosimilars Market, 2009–2016

Figure 56: Biosimilars Approval Pathways in the US and Europe, Italy, Drivers and Barriers for the Biosimilars Market, 2009–2016

Figure 57: Biosimilars Approval Pathways in the US and Europe, Japan, Evolution of Regulatory Pathway, November 2009

Figure 58: Biosimilars Approval Pathways in the US and Europe, Japan, Drivers and Barriers for the Biosimilars Market, 2009–2016

Figure 59: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Sandoz, 2010

Figure 60: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Sandoz, SWOT, 2010

Figure 61: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Teva, 2010

Figure 62: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Teva, SWOT, 2010

Figure 63: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Hospira Inc, 2010

Figure 64: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Hospira, SWOT, 2010

Figure 65: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Dr. Reddy’s Laboratories, 2010

Figure 66: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Dr. Reddy’s Laboratories, SWOT, 2010

Figure 67: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Biocon, 2010

Figure 68: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Biocon, SWOT, 2010

Figure 69: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Biopartners, 2010

Figure 70: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Biopartners, SWOT, 2010

Figure 71: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Watson Pharmaceuticals, 2010

Figure 72: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Watson Pharmaceuticals, SWOT, 2010

Figure 73: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, STADA Arzneimittel AG, 2010

Figure 74: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, STADA Arzneimittel AG, SWOT, 2010

Figure 75: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Reliance Life Sciences, 2010

Figure 76: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Reliance Life Sciences, SWOT, 2010

Figure 77: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Intas Biopharmaceuticals, 2010

Figure 78: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Intas Biopharmaceuticals, SWOT, 2010

Figure 79: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Celltrion Inc, 2010

Figure 80: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Celltrion Inc, SWOT, 2010

Figure 81: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, 3SBio Inc, 2010

Figure 82: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, 3SBio Inc, SWOT, 2010

License Details
Electronic PDF copy delivered via email. Report can be used by individual purchaser only.
Single User Licence
$3500
Electronic PDF copy delivered via email. Report can be shared by unlimited users within one corporate location, e.g. a regional office.
Site Licence
$7000
Electronic PDF copy delivered via email. Report can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company.
Global Licence
$10500
Email to a colleague Enquire Before Buying
Prefer to speak to a team member? Call us on:
+44 161 359 5414
Or click here to contact us
Secure Payments
Cards