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
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
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
