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Top 5 Generic Opportunities in Pharmaceuticals to Watch in 2019: Perspective for the Future

DUBLIN, Jan. 10, 2020 /PRNewswire/ -- 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/hk3myg

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