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市場調査レポート
バイオシミラー製造上の課題克服
Meeting the Challenges of Manufacturing Biosimilars
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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?
Scope
- 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.
Companies Mentioned in This Spectrum Report
- Abbott Laboratories
- Amgen
- Biocon
- Biogenerix
- BioPartners
- CoGenesys
- CT Arzneimittel
- Dr. Reddy' s Laboratories
- Eli Lilly
- Genentech
- Genzyme
- GlycoFi
- Hexal
- Hospira
- Medice
- Momenta Pharmaceuticals
- Neose
- Novartis
- Novo Nordisk
- Pfi zer
- Procognia Israel
- Prolong Pharmaceuticals
- Ranbaxy
- Ratiopharm
- Sandoz
- Stada
- Teva Pharmaceutical
- Wockhardt
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- The Regulatory and Legislative Landscape
- 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
Sidebar
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
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