Biosimilar Market Trends Report 2019: EU Guidelines, US Guidelines, Interchangeability, Patent and Patent Dance Issues - ResearchAndMarkets.com

DUBLIN--()--The "Biosimilar Market Trends 2019" report has been added to ResearchAndMarkets.com's offering.

Biopharmaceuticals are synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies, and nucleic acids such as DNA or RNA. Generic products are non-patented chemical and therapeutic equivalents of brand name drugs.

However, biosimilars are not generic biologics because there can be no generic form of biologics due to the complex process of creating biologics. Biosimilar Market Trends 2019 is designed to provide a snapshot of issues and trends that are affecting the biosimilar market today, along with the various strategies being used by both innovator companies and generic companies in the developing world of biosimilars.

The issues and trends surrounding the prescription biosimilars pharmaceutical market are many but, as the pharmaceutical industry has experienced in the past, the generics industry is tough, resilient and determined. The generics industry has managed to overcome obstacles and prevail. It is expected that with due diligence, the generics industry will not only break into the biotechnology market but create formidable competition for brand biotech companies and reap substantial profits.

However, the report does note several issues that will first need to be addressed, including:

  • Legislative Issues and Guidelines
  • Interchangeability
  • Patent and Patent Dance Issues
  • Provider Education
  • Switching Concerns
  • Innovator Strategies and Challenges
  • Reimbursement Issues
  • Biosimilar Naming and Labeling

The publisher has identified the biopharmaceuticals that have lost patent protection and are the first products to reach the market. Some of these products are relatively simple in structure (by biotech complexity) such as the insulins and human growth hormones, while others are extremely difficult to process.

The publisher also has identified biopharmaceuticals for future expired biologic patents. Biosimilar market data provided include:

  • Select Marketed Biologics with Expired Patents
  • Select Marketed Biologics with Active Patents

The development of the global market for biosimilars presents an opportunity for cost savings and improved health outcomes. Despite the benefits, the market has been slow to develop and is only a fraction of its potential. The path to making biosimilars as common as traditional generic drugs has historically been a slow and agonizing process for all involved; but there are some major industry changes in the past couple years that have extended the market, improved regulatory processes and brought more biological options to health professionals and patients around the world.

Biosimilar Market Trends 2019 examines as well legislative and patent issues. Global biosimilars are continuing to grow worldwide with emerging regions playing a larger role. As demonstrated by analysis of various countries, many emerging markets are establishing biosimilar regulatory pathways, providing increasing opportunities for biosimilar development.

However, there are still regulatory and operational hurdles to address. Uniform clinical studies remain an issue and harmonization between country regulations is still concerning. Guidelines in many emerging countries are patterned after European Medicines Agency (EMA) guidelines, which is helping to provide some semblance of comparable harmonization in requirements.

Issues discussed in the report include:

  • EU Guidelines
  • US Guidelines
  • Interchangeability
  • Patent and Patent Dance Issues

Key Topics Covered:

1. Executive Summary

  • Overview
  • Scope and Methodology
  • Size and Growth of the Market
  • The Global Market for Biosimilars
  • Trends Affecting the Market
  • Market Outlook

2. Introduction and Overview

  • Biosimilars Overview
  • What's Been Going On in the Market?
  • Europe
  • US
  • Rest of World
  • Industry Leaders

3. Biosimilar Pharmaceuticals for Expired Biologic Patents

4. Biosimilar Pharmaceuticals for Future Expired Biologic Patents

5. Biosimilar Market Activity

  • Market Summary
  • Development Overview
  • Competitor Analysis
  • Europe and Biosimilars
  • European Union Biosimilar Market Overview
  • United States and Biosimilars
  • United States Biosimilar Market Overview
  • Rest of World and Biosimilars
  • Rest of World Biosimilar Market Overview
  • Japan
  • India
  • China
  • South Korea
  • Australia

6. Legislative and Patent Issues

  • Overview
  • EU Guidelines
  • US Guidelines
  • Interchangeability
  • Patent and Patent Dance Issues

7. Other Industry Issues and Trends

  • Provider Education
  • Switching Concerns
  • Innovator Strategies and Challenges
  • Reimbursement Issues
  • Biosimilar Naming and Labeling

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

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Biosimilars and Biosuperiors

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Biosimilars and Biosuperiors