Loading... Please wait...Connecting to intelligent information in the electronic age.
New PublicationsBIOGENERICS MCP-1537
A GLOBAL STRATEGIC BUSINESS REPORT
CONTENTS
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
II. EXECUTIVE SUMMARY
1. Market Overview II-1
Biogenerics Spell Opportunities II-1
Patent Expiration of Biotech Medicines Paves Way for New
Generation Biogenerics II-1
Patent Expiration of Major Biotechnology Products before 2007 II-2
Market Structure II-2
Potential Key Competitors in the Biogenerics Space II-2
Entry Barriers for Biogenerics II-3
Comparison of Entry Barriers for Biogenerics in Select
Global Markets II-3
Is Commercialization of Biogenerics Possible? II-3
Will Biopharmaceutical Market Witness Intense Competition
from Generic Firms? II-3
Branded Vs Generics Drugs - The Debate Continues II-3
Growth Impediments II-4
Heavy Investment II-4
Shortage of Manufacturing Capacity II-4
Lack of Clear Regulatory Mechanism II-4
Overview of Select Markets II-5
United States II-5
Biogenerics to Exhibit Slow Start II-5
Europe II-5
Australia II-6
India - Emerging Player in the Biogeneric Market II-6
2. Trends and Issues II-8
US FDA Under Pressure II-8
Entry Barriers Limit Competition in Biogenerics Market II-8
Bend the Rule or Not - Authorities in Dilemma II-8
Biogenerics Market Gains Support from Other Institutions II-8
Generic Drug Producers Adopt "Evergreening" Concept II-8
Biogenerics Need to Conform to the Production Norms of
Original Products II-9
3. Drug Approval Process in US and Europe II-10
Bioequivalence Tests - Mandatory Requirement for Generics II-10
Approval Process in the US II-10
Hatch Waxman Act and FDA Approval Process II-10
ANDA Review Process II-11
Generic Exclusivity II-13
30-Month Stay Period II-13
180-Days Exclusivity Period7 II-13
Time Period for Generic Approval II-13
Approval Process in Europe II-13
Generic Companies Face Strict Regulations for Approval II-13
Data Exclusivity II-13
4. Product Overview II-15
What are Biogenerics? II-15
Biogenerics - Generic Version of Biopharmaceuticals II-15
Biopharmaceuticals II-16
Biogenerics Versus Conventional Generics II-17
Manufacturing Process of Biogenerics - A Debatable Issue II-17
5. Recent Industry Activity II-18
Teva Acquires IVAX Corporation II-18
Biopartners Bags EU Marketing Approval for Valtropin II-18
Sandoz Bags EC Marketing Approval for Omnitrope II-18
Omnitrope Receives US FDA Approval II-18
Biocon Limited Partners with Vaccinex Inc II-18
Novartis Pockets Hexal AG II-18
Mayne's Pharma Division Collaborates with Pliva II-19
Clinigene Initiates Clinical Trials on Biocon's EGFR
Monoclonal Antibody II-19
Barr Laboratories Signs Agreement with Pliva for Developing
G-CSF II-19
Pliva Croatia Bags Approval for Biogeneric EPO II-20
Teva Pharmaceutical Industries Acquires SICOR II-20
Biocon Launches Bio-Insulin II-20
Cipla in Strategic Alliance with Dongbao Pharmaceutical
Company Ltd II-20
Crucell N.V. Signs a Licensing Agreement with Gene Medicine
Japan Inc II-20
6. Focus on Select Players II-21
Biocon Limited (India) II-21
BioPartners (Switzerland) II-21
BioGeneriX AG (Germany) II-21
Cangene Corporation (Canada) II-21
Cipla Ltd. (India) II-21
Dr. Reddy's Laboratories (India) II-22
GeneMedix (UK) II-22
LG Life Sciences (Korea) II-22
Pliva d.d. (Croatia) II-23
Ranbaxy Laboratories Limited (India) II-23
Sandoz International GmbH (Germany), a Unit of Novartis II-24
Stada Arzneimittel (Germany) II-24
Teva Pharmaceutical Industries Ltd. (Israel) II-25
Teva Pharmaceuticals USA (USA) II-25
Wockhardt Limited (India) II-26
7. Global Market Perspective II-27
Table 1: Worldwide Market for Biogenerics - Market Projections
for US, Europe and Rest of World with Annual Sales Figures in
US$ Million for Years 2007 through 2013 (includes
corresponding Graph/Chart) II-27
Table 2: Worldwide 6-Year Perspective for Biogenerics -
Percentage Breakdown of Dollar Sales for US, Europe and Rest
of World for Years 2007, 2010 & 2013 (includes corresponding
Graph/Chart) II-27
III. COMPETITIVE LANDSCAPE
Choose a currency below to display product prices in the selected currency.