Meeting the Challenges of Manufacturing Biosimilars

Published by: Decision Resources

Published: Nov. 25, 2008 - 26 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

The Regulatory and Legislative Landscape

Europe

United States

Manufacturing Issues

The Production Process

The Importance of Glycosylation

Determining Comparability of Recombinant Protein Drugs

Can Comparability Assessment Analytics Support Biosimilars Development and Manufacturing?

Second-Generation Biopharmaceuticals

Companies Marketing Biosimilars

Sandoz

Teva Pharmaceutical

BioPartners

Ranbaxy

Dr. Reddy’s Laboratories

Will Big Biotechs and Big Pharmas Participate in Biosimilars Manufacturing?

Select Companies with Technology for Biosimilars and Second-Generation Biopharmaceuticals

Momenta Pharmaceuticals

Procognia Israel

Prolong Pharmaceuticals

GlycoFi

CoGenesys

Outlook for Biosimilars

About the Author

Sidebar

The Case of Myozyme

Tables

1. Patent Expiry Dates for Key Biologic Brands

2. Biosimilar Agents Approved or Authorized in the European Union and United States

3. Biosimilars Versus Second-Generation Biopharmaceuticals: Development, Exclusivity, and Pricing

4. Select Companies Marketing/Developing Biosimilars/Second-Generation Biopharmaceuticals or Offering Related Technology

Figures

1. Top Biologics Brands: Company-Reported Worldwide Sales, 1998-2007

2. The 100 Best-Selling Therapies Worldwide, by Technology, 2007

3. General Biopharmaceutical Manufacturing Scheme

Abstract

Introduction

Branded biologics have, until recently, been immune to generics competition; however, the approval of biosimilars in Europe heralds a changing landscape. Legislation enabling the approval of biosimilars is stalled in the U.S. Congress but could pass in 2009, and President-elect Obama supports establishing a biosimilars regulatory framework. Complex manufacturing issues pose some of the most signifi cant challenges to companies seeking to compete in this potentially lucrative market.

Get the Answers You Need to Shape Your Strategy

• Generic versions of off-patent biologics, known as biosimilars, have recently entered European markets. What biosimilar products have been approved in Europe? What will be required to bring biosimilars to market in the United States?
• A major barrier to the development of biosimilar drugs is the diffi culty of manufacturing biologics that are comparable to the original branded product. What are the key issues in ensuring protein drug comparability? What impact do changes in manufacturing processes have on biopharmaceutical products? Can analytic tools used for comparability assessment at innovator companies be applied to biosimilars manufacturing?
• Second-generation biopharmaceuticals are drugs that differ from the original products in formulation or method of delivery. What are the strategic advantages of second-generation biopharmaceuticals? What companies have proprietary technology for creating second-generation pharmaceuticals?
• The entrance of biosimilars in the U.S. market will provide opportunities to many players. Which companies are best positioned to compete in the biosimilars market? Which companies have proprietary technology to support biosimilars development and manufacturing?

• The regulatory and legislative landscape: Europe, the EMEA, the United States, the FDA.
• Manufacturing issues: the production process, glycosylation, determining comparability, comparability assessment analytics.
• Second-generation biopharmaceuticals: approval process, Aranesp, defensive strategy.
• Companies marketing biosimilars: generics manufacturers, specialty companies, Indian generics companies.
• Participation of Big Biotech and Big Pharma: opportunity versus threat, capabilities, pharmaceutical company interest and involvement.
• Technology companies: biosimilar analytics companies, second-generation biopharmaceuticals technologies, alternative manufacturing technology, collaborations, acquisitions.

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 300,000 market research reports, company profiles and country profiles from over 700 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.