Dublin, Jan. 08, 2020 (GLOBE NEWSWIRE) -- The "Top 5 Generic Opportunities in Pharmaceuticals to Watch in 2019: Perspective for the Future" report has been added to ResearchAndMarkets.com's offering.

The 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

Key Topics Covered

Chapter 1 Introduction

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

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

For more information about this report visit https://www.researchandmarkets.com/r/lhtes

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