克服生物學名藥的製造課題

克服生物學名藥的製造課題 是由出版商Decision Resources, Inc.在2008年11月所出版的。 這份英文市場調查報告書包含26 Pages 價格從美金2250起跳。

簡介

目錄

Abstract

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.

• 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.

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
  • 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

• 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

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