Top 5 Generic Opportunities in Pharmaceuticals to Watch in 2019: Perspective for the Future
REPORT INCLUDES:
- An overview of top five opportunities for generic or biosimilar drugs in pharmaceuticals market 2019
- Coverage of generics and discussion on their characteristics
- Information on Hatchmann-Wax act and its effect on market competitiveness impacting pricing and development of original drugs
- Insights on the key challenges and opportunities in the development of generics or biosimilar drugs
- Description of product class, mechanism of action, indications and contraindications,
- Clinical and generic development of the prominent products
- Detailed patent analysis i.e. expiry and exclusivity, regulations and policies and patent expiry and market impact
- Profiles of key competitors engaged in the development of generic and biosimilars
CHAPTER 1 INTRODUCTION
Study Goals and Objectives
Scope of Report
Information Sources
Methodology
Analyst's Credentials
CHAPTER 2 PERSPECTIVES OF GENERICS AND BIOSIMILAR BUSINESS
Overview of Generics and Biosimilars
Generics
Types of Generics
Biosimilars
Lifecycle of a Biosimilar Drug
Development of a Biosimilar
Manufacturing of a Biosimilar
Preclinical Studies and Validation of a Biosimilar
Clinical Trials
Generics vs. Biosimilars
Market Landscape of Generics and Biosimilars
Competitive Landscape of Generics and Biosimilars
Trends
Structure of the Generics Industry
Biosimilars Competitive Landscape
Bio-intellectual Companies
Opportunistic Companies
Emerging Trends in Biosimilar Industry Structure
CHAPTER 3 PATENTS & PATENT CLIFFS
Patents and IP
Supplementary Protection Certificates
Patent Regulations in Favor of Branded Biologics
Patent Regulations in Favor of Biosimilars-Emerging Trends
CHAPTER 4 REGULATION OF GENERICS AND BIOSIMILARS BUSINESS
United States
European Union
EU Marketing Authorization Systems
Types of Applications
Regulation of Biosimilars
EU Provisions
Evolving Situation in the U.S.
User Fees
Defensive Strategies by “Big Pharma”
Authorized Generics
User Fees
Changing Climate for Generics
Situation in Europe
CHAPTER 5 PRODUCT PROFILE ANALYSIS
Overview
Profile Analysis
Xolair
Mechanism of Action
Indications and Contraindication
Dosage and Administration
Historical Net Sales and Growth Rates of Xolair for Novartis
Timeline of Key Events-Xolair (Omalizumab)
Key Regulatory Approvals
Pricing and Annual Cost of Xolair Associated with Treatment
Factors Favoring Generic/Biosimilar Development of Xolair
Biosimilar Clinical Developments
Profiles Key Companies engaged in the Business/Development of Xolair and Biosimilar Omalizumab
Companies Developing Biosimilar Version of Omalizumab
Revlimid
Mechanism of Action
Indications and Contraindication
Dosage and Administration
Historical Net Sales and Growth Rates
Timeline of Key Events-Revlimide (Lenalilomide)
Pricing and Annual Cost of Revlimid Associated with Treatment
Factors Influencing Generic Development
Business & Legal Challenges
FDA’s Campaign of “Naming and Shaming of Branded Pharmaceuticals Adopting Anti-Trade Practices”
Revlimid Generics Development/Marketed Drugs
Company Profiles
Generic Manufacturers of Revlimid
Orencia
Mechanism of Action
Indications and Contraindication
Dosage and Administration
Historical Net Sales and Growth Rates of Orencia for Bristol-Meyers Squibb
Timeline of Key Events-Orencia
Pricing and Annual Cost of Orencia Associated with Treatment
Factors Favoring Generic/Biosimilar Development of Orencia
Biosimilar Clinical Developments
Profiles Key Companies Engaged in the Business/Development of Xolair and Biosimilar Omalizumab
Companies Developing Biosimilar Version of Omalizumab
Pradaxa
Mechanism of Action
Indications
Adverse Reaction
Dosage and Administration
Historical Net Sales and Growth Rates of Pradaxa
Clinical Development
Timeline of Key Events-Pradaxa (Dabigatran)
Pricing and Annual Cost of Pradaxa
Factors Favoring Generic Development of Pradaxa
Generics Clinical Developments
Profiles of the Pradaxa Manufacturer
Generic Manufacturer of Pradaxa
Gilenya
Mechanism of Action
Indications
Dosage and Administration
Historical Net Sales and Growth Rates of Gilenya for Novartis
Timeline of Key Events-Gilenya
Pricing and Annual Cost of Gilenya Associated with Treatment
Factors Favoring Generic/Biosimilar Development of Gilenya
Generic Clinical Developments
Profiles Key Companies Engaged in the Business/Development of Gilenya
Companies Developing Generic Version of Gilenya
CHAPTER 6 CONCLUSION
Improved Understanding of Pharmaceutical Technologies
Access to Pharmaceutical Technologies and Production Methods
Shift in the Business Model of Pharmaceutical Industry
Challenges
Future Perspectives
Study Goals and Objectives
Scope of Report
Information Sources
Methodology
Analyst's Credentials
CHAPTER 2 PERSPECTIVES OF GENERICS AND BIOSIMILAR BUSINESS
Overview of Generics and Biosimilars
Generics
Types of Generics
Biosimilars
Lifecycle of a Biosimilar Drug
Development of a Biosimilar
Manufacturing of a Biosimilar
Preclinical Studies and Validation of a Biosimilar
Clinical Trials
Generics vs. Biosimilars
Market Landscape of Generics and Biosimilars
Competitive Landscape of Generics and Biosimilars
Trends
Structure of the Generics Industry
Biosimilars Competitive Landscape
Bio-intellectual Companies
Opportunistic Companies
Emerging Trends in Biosimilar Industry Structure
CHAPTER 3 PATENTS & PATENT CLIFFS
Patents and IP
Supplementary Protection Certificates
Patent Regulations in Favor of Branded Biologics
Patent Regulations in Favor of Biosimilars-Emerging Trends
CHAPTER 4 REGULATION OF GENERICS AND BIOSIMILARS BUSINESS
United States
European Union
EU Marketing Authorization Systems
Types of Applications
Regulation of Biosimilars
EU Provisions
Evolving Situation in the U.S.
User Fees
Defensive Strategies by “Big Pharma”
Authorized Generics
User Fees
Changing Climate for Generics
Situation in Europe
CHAPTER 5 PRODUCT PROFILE ANALYSIS
Overview
Profile Analysis
Xolair
Mechanism of Action
Indications and Contraindication
Dosage and Administration
Historical Net Sales and Growth Rates of Xolair for Novartis
Timeline of Key Events-Xolair (Omalizumab)
Key Regulatory Approvals
Pricing and Annual Cost of Xolair Associated with Treatment
Factors Favoring Generic/Biosimilar Development of Xolair
Biosimilar Clinical Developments
Profiles Key Companies engaged in the Business/Development of Xolair and Biosimilar Omalizumab
Companies Developing Biosimilar Version of Omalizumab
Revlimid
Mechanism of Action
Indications and Contraindication
Dosage and Administration
Historical Net Sales and Growth Rates
Timeline of Key Events-Revlimide (Lenalilomide)
Pricing and Annual Cost of Revlimid Associated with Treatment
Factors Influencing Generic Development
Business & Legal Challenges
FDA’s Campaign of “Naming and Shaming of Branded Pharmaceuticals Adopting Anti-Trade Practices”
Revlimid Generics Development/Marketed Drugs
Company Profiles
Generic Manufacturers of Revlimid
Orencia
Mechanism of Action
Indications and Contraindication
Dosage and Administration
Historical Net Sales and Growth Rates of Orencia for Bristol-Meyers Squibb
Timeline of Key Events-Orencia
Pricing and Annual Cost of Orencia Associated with Treatment
Factors Favoring Generic/Biosimilar Development of Orencia
Biosimilar Clinical Developments
Profiles Key Companies Engaged in the Business/Development of Xolair and Biosimilar Omalizumab
Companies Developing Biosimilar Version of Omalizumab
Pradaxa
Mechanism of Action
Indications
Adverse Reaction
Dosage and Administration
Historical Net Sales and Growth Rates of Pradaxa
Clinical Development
Timeline of Key Events-Pradaxa (Dabigatran)
Pricing and Annual Cost of Pradaxa
Factors Favoring Generic Development of Pradaxa
Generics Clinical Developments
Profiles of the Pradaxa Manufacturer
Generic Manufacturer of Pradaxa
Gilenya
Mechanism of Action
Indications
Dosage and Administration
Historical Net Sales and Growth Rates of Gilenya for Novartis
Timeline of Key Events-Gilenya
Pricing and Annual Cost of Gilenya Associated with Treatment
Factors Favoring Generic/Biosimilar Development of Gilenya
Generic Clinical Developments
Profiles Key Companies Engaged in the Business/Development of Gilenya
Companies Developing Generic Version of Gilenya
CHAPTER 6 CONCLUSION
Improved Understanding of Pharmaceutical Technologies
Access to Pharmaceutical Technologies and Production Methods
Shift in the Business Model of Pharmaceutical Industry
Challenges
Future Perspectives
LIST OF TABLES
Table 1: List of Biosimilars Produced in E. Coli
Table 2: List of Biosimilars Produced in Mammalian Cells
Table 3: Number of Approved Biosimilars, by Type
Table 4: Generics vs. Biosimilars
Table 5: List of Key Products
Table 6: Sales of Xolair, Through 2018
Table 7: Approved Indications for Use of Revlimid
Table 8: Sales of Revlimid, Through 2018
Table 9: Dosage Recommendation Per Patient Weight
Table 10: Sales of Orencia, Through 2018
Table 11: Sales of Pradaxa, Through 2018
Table 12: Sales of Gilenya, Through 2018
Table 1: List of Biosimilars Produced in E. Coli
Table 2: List of Biosimilars Produced in Mammalian Cells
Table 3: Number of Approved Biosimilars, by Type
Table 4: Generics vs. Biosimilars
Table 5: List of Key Products
Table 6: Sales of Xolair, Through 2018
Table 7: Approved Indications for Use of Revlimid
Table 8: Sales of Revlimid, Through 2018
Table 9: Dosage Recommendation Per Patient Weight
Table 10: Sales of Orencia, Through 2018
Table 11: Sales of Pradaxa, Through 2018
Table 12: Sales of Gilenya, Through 2018
LIST OF FIGURES
Figure 1: Xolair Key Events, 2003-2018, Post 2020
Figure 2: Revlimid Key Events, 2005-2019
Figure 3: Orencia Key Events, 2005-2019
Figure 4: Pradaxa Key Events, 2008-2017
Figure 5: Gilenya Key Events, 2010-2019
Figure 1: Xolair Key Events, 2003-2018, Post 2020
Figure 2: Revlimid Key Events, 2005-2019
Figure 3: Orencia Key Events, 2005-2019
Figure 4: Pradaxa Key Events, 2008-2017
Figure 5: Gilenya Key Events, 2010-2019
