Negotiating The Emerging Biosimilars Landscape

Summary

Negotiating the Emerging Biosimilars Landscape
Key developments in the regulatory environment

As regulatory obstacles to biosimilars development have become increasingly resolved, a growing number of opportunities have been created for generics companies in the biopharmaceutical market, which according to IMS data was valued at $85.9 billion in 2007. Conservative projections estimate that sales of biopharmaceutical products will exceed $135 billion by 2011. With some of the earliest biopharmaceuticals having already lost patent protection, the originators of biopharmaceutical products are facing intense competition from generics developers. In response, originators are resorting to a range of defensive tactics, including the reformulation of existing products to improve efficacy, the implementation of more efficient delivery systems and the pursuit of high-level intellectual property (IP) battles.

'Negotiating the Emerging Biosimilars Landscape' is a new report published by Business Insights that examines the structure of the biopharmaceutical industry and the strategic approaches taken to alleviate the threat posed by the biosimilar market. The key factors affecting market access within the biosimilars market are assessed and the latest issues surrounding bioequivalence are examined. This report also provides a comprehensive review of the current legislative and regulatory positions of key geographic regions in addition to evaluating their anticipated future legislative changes and outcomes.

Key Findings

European Union guidelines have been prepared which authorise the use of specific therapeutic biopharmaceutical medicines as biosimilars. However, despite the range of current European guidelines produced by the EMEA, many European governments have issued laws prohibiting the automatic substitution of original products.

No approval pathway for biosimilars (FOB) exists in the USA, and one is unlikely to exist before 2010. A complex range of Acts and Bills have failed to resolve a number of outstanding legal and regulatory issues.

India's biopharmaceutical industry is projected to grow to almost $5 billion by the end of 2010, representing annual growth in excess of 30%. However, despite WTO membership and recent advances in compliance with international regulatory/intellectual property laws, there remains no formal regulatory framework for biosimilars in India or China.

Health Canada has not yet publicly announced a legal or regulatory framework for biosimilar approval, and no legal framework for biosimilars currently exists in Japan. New regulatory frameworks and biosimilar guidelines are currently under development in both countries.

Use this report to...

• Identify and respond to the challenges and threats posed by the emergence of the biosimilars industry with this report's examination of key trends and strategic approaches used by the biopharmaceutical industry to protect market share and intellectual property.
• Examine details of expired patents or impending patent expiries for first-gen biopharmaceuticals derived from recombinant DNA such as interferons, human insulin and insulin analogs, monoclonal antibodies (Mab) growth hormone and epoietins.
• Evaluate the legislative and regulatory requirements for biosimilars across key geographic regions including Europe, the US, Japan, Australia, Canada as well as the strategically important emerging markets of China and India.
• Assess the factors affecting biosimilar market access with this report's analysis of the drivers and restraints to biosimilar approval, use and uptake, in addition to an investigation of the problems associated with determining bioequivalence.

Explore issues including...

Impending patent expiries. The critical challenge facing the biopharmaceutical industry is the expiry or pending expiry of patents for first generation biopharmaceuticals derived from recombinant DNA such as interferons, growth hormone and epoietins.

Defensive strategies. As part of efforts to protect the market share of products with impending patent expiries, originator biopharmaceutical companies have begun to protect intellectual property and engage in strategic alliances, joint ventures and mergers between themselves and major pharma companies.

Geographical disparities in biosimilar legislation. Different geographic regions have varying legislative approaches to the regulation and/or approval of biosimilars. Such discrepancies often lead to misunderstandings and can result in complexity and complication during the approval process.

Discover...

• Which biopharmaceutical companies are at risk from product patent expires?
• What is the status of the analytical techniques used for determining bioequivalence?
• What tactics prove most effective for originator biopharmaceutical companies who wish to protect their market position?
• What effect the market entry of second generation biopharmaceuticals by originator companies have on the biosimilars market?
• What are the growth drivers and restraints of the biosimilars market?
• How are global healthcare costs influenced by biosimilar market entry prospects?
• What is the current legislative and regulatory status of biosimilars in Europe and the US?
• How will China and India influence the biopharmaceutical and biosimilars market in the future?

Contents

• Negotiating the Emerging Biosimilars Landscape Executive Summary
  • Chapter 1: Biosimilars and the biosimilars industry
  • Chapter 2: Factors affecting market access for biosimilars
  • Chapter 3: The European position on biosimilars
  • Chapter 4: The United States' position on biosimilars
  • Chapter 5: Position on biosimilars: China and India
  • Chapter 5: Position on biosimilars: other geographic regions
• Chapter 1 Biosimilars and the biosimilars industry
  • Summary
  • Introduction and Overview
  • Biotechnology in Healthcare and the Biotechnology Industry
  • Biosimilars: terminology, definitions and nomenclature
  • Biosimilars definitions and terminology
  • Structure of the healthcare based Biotechnology Industry
  • The pharmaceutical-biopharmaceutical relationship
  • Emergence of the biopharmaceutical sector
  • Biopharmaceutical sales by therapeutic area and leading companies
  • Biopharmaceutical sales by therapeutic area
  • Leading biopharmaceutical companies
  • Characteristics and strategy of the biopharmaceutical industry
  • Strategic alliances, joint ventures and mergers
  • High technology and intellectual property issues
  • High venture capital investment
  • High risk and costs associated with drug development
  • Challenges and major Issues
  • The threat from biosimilars
  • Erythropoietins (EPOs)
  • Interferons
  • Human Insulin and Insulins Analogues
  • Monoclonal antibodies (MAb)
  • Lack of regulatory guidelines and legislation controlling biosimilars
  • Product complexity of biopharmaceuticals
  • Differences in immunogenicity
  • Differences in processing and manufacturing
• Chapter 2 Factors affecting market access for biosimilars
  • Summary
  • Introduction
  • Market dynamics
  • Market drivers influencing biosimilars approval, use and uptake
  • Emergence of biosimilars as patents of leading biopharmaceuticals expire
  • Biosimilars predicted to reduce global healthcare costs
  • Advances in manufacturing and proving equivalence provide new impetus to manufacturers
  • Lower priced biosimilars enable greater patient coverage and market penetration
  • EMEA legislation relating to biosimilars sets standard for market development of biosimilars in Europe
  • Market restraints influencing biosimilars approval, use and uptake
  • Political lobbying by branded companies
  • Resistance to substitution of products from pharmacists, physicians and patients
  • R&D and commercialization of second generation biopharmaceuticals by innovator companies
  • Manufacturing issues related to bioequivalence and substitutability of branded biopharmaceuticals
  • Biosimilars: The cost and complexity of development
  • Lack of legislation restricts growth of biosimilars in the United States
  • Determining the bioequivalence or essential similarity of biosimilars
  • Proving equivalence of therapeutic proteins
  • Glycosylation
  • Mammalian cell culture processes
  • Glyco-engineered yeast cell lines
  • Proving equivalence of the end product
  • Opinions from originator companies and supporting associations
  • Opinions from generic manufacturers and supporting associations
  • Demonstrating therapeutic equivalence
  • Assays for confirming the presence of antibodies
  • Assays for dissecting the specificity of antibodies
  • Neutralization assays
• Chapter 3 European position on biosimilars
  • Summary
  • European regulation on biosimilars
  • EU legal and regulatory framework for biosimilar products
  • Creation of the European Agency for the Evaluation of Medicinal Products (EMEA)
  • Directive 2001/83/EC
  • Directive 2003/63/EC
  • Directive 2004/27/EC
  • Regulatory framework for biosimilars in Europe
  • Principle European guidelines
  • EU specific guidelines on biosimilars (quality & clinical and non clinical issues)
  • EU product specific guidelines on biosimilars
  • Concerns over regulatory, clinical and marketing issues
  • Prohibition of automatic substitution of biosimilars in European countries
  • National interpretations and implementation of the Bolar Clause
  • Patient, pharmacist and physician acceptability of biosimilars
  • Reimbursement of biosimilars in Europe
• Chapter 4 United States position on biosimilars
• Summary
  • Regulation and legislation affecting follow-on biologics in the US
  • Historical background and current legislation in the US
  • Historic legislative developments for biosimilars in the US
  • Recent congressional legislation
  • Access to Life-Saving Medicine Act (H.R. 1038/S.623)
  • Patient Protection and Innovative Biologic Medicines Act (H.R. 1956)
  • S.1695 The Biologics Price Competition and Innovation Act of 2007
  • The Pathways for Biosimilars Act (H.R. 5629)
  • The Federal Trade Commission reviews biosimilars and competition
  • (Notice Billing Code: 6750-01-S)
  • The future outlook for biosimilars in the USA
• Chapter 5 Position on biosimilars: China and India
  • Summary
  • China
  • Healthcare regulation and legislation in China
  • The Chinese biopharmaceutical and biosimilar industry
  • Regulation and legislation of biologicals in China
  • India
  • Healthcare regulation and legislation in India
  • Establishment of the Central Drug Authority (CDA)
  • Improvements to the administration of biotechnologies in India
  • The biopharmaceutical and biosimilar industry in India
  • Regulation and legislation of biologicals in India
• Chapter 6 Position on biosimilars: other geographic regions
  • Summary
  • Australia
  • Regulation and legislation affecting biopharmaceuticals in Australia
  • Regulatory approval process for medicines in Australia
  • Regulatory approval process for biosimilars in Australia
  • Canada
  • Regulation and legislation affecting biopharmaceuticals in Canada
  • Regulatory approval process for medicines in Canada
  • Current position on subsequent entry biologics in Canada
  • Interim regulatory status of sebs in Canada
  • Japan
  • Healthcare regulation and legislation in Japan
  • Restructuring of principle regulatory agencies in Japan
  • Major changes to pharmaceutical laws enacted April 2005
  • The biopharmaceutical and biosimilar industry in Japan
  • Current position on follow-on biologicals (fobs) or biosimilars
• Chapter 7 Appendix
  • Methodology statement
  • Primary Data and Information Gathering
  • Secondary data and information gathering
  • Market share analysis and market forecast predictions
  • Definitions of Product-Life Cycle stages
  • Glossary of abbreviations and acronyms
  • Glossary of Terms
  • Index
• List of Figures
  • Figure 1.1: Evolution of the biopharmaceutical corporation
  • Figure 1.2: Comparison of global sales by biopharmaceutical class 2007
  • Figure 1.3: Challenges and Issues Affecting the Biopharmaceutical Industry
  • Figure 1.4: Predicted market share of multiple sclerosis drugs (2007-2017)
  • Figure 1.5: Estimated last patent expiry dates of selected proteins
  • Figure 2.6: Impact of second generation biopharmaceuticals on erythropoietin market development (2000-2006)
  • Figure 2.7: The process of determining therapeutic equivalence
  • Figure 2.8: Analytical techniques used to physicochemically characterize complex glycoproteins
  • Figure 3.9: Structure of the EMEA
  • Figure 3.10: Timeline of EU guidelines on biosimilars
  • Figure 4.11: Timeline of US guidelines on follow-on-biologics
  • Figure 5.12: Biopharmaceutical and pharmaceutical sales revenue in China (2005)
  • Table 1.1: Terminology used to describe generic biopharmaceuticals
  • Table 1.2: Top 20 Pharmaceutical companies ranked by revenue (2007)
  • Table 1.3: Top 10 Biopharmaceutical companies ranked by revenues (2007)
  • Table 1.4: Biopharmaceutical sales by therapeutic area, 2007
  • Table 1.5: Top 10 biopharmaceutical companies biopharmaceutical sales $m (2003-2007) by ATC3, therapeutic products
  • Table 1.6: Top 10 biopharmaceutical companies sales $m (2003-2007) by ATC3, therapeutic products
  • Table 1.7: Interferons on the market and patent expiries
  • Table 1.8: Multiple sclerosis drugs on the market and patent expiries
  • Table 1.9: Recombinant insulin products on the market and patent expiries
  • Table 1.10: Summary of key structural data for selected therapeutic protein products
  • Table 1.11: Comparison of biopharmaceuticals versus chemical low molecular weight drugs
  • Table 2.12: Approved biosimilars EMEA and recommended authorizations
  • Table 2.13: Productivity increases over the last 20 years in mammalian cell culture
  • Table 2.14: Physicochemical characterization methodology of non-glycosylated proteins
  • Table 3.15: Summary of biosimilar overarching guideline (EMEA/CHMP/437/04)
  • Table 3.16: General EU guidelines on biosimilars
  • Table 3.17: Summary of Biosimilar Quality Guideline (EMEA/CHMP/49348/05)
  • Table 3.18: Summary of Biosimilar Non Clinical Guideline (EMEA/CHMP/42832/05)
  • Table 3.19: Summary of Biosimilars (non) Clinical Guideline Principles for EMEA/CHMP/42832/05
  • Table 3.20: EU product specific guidelines on biosimilars
  • Table 3.21: EU revisions to product specific guidelines on biosimilars
  • Table 5.22: Major biosimilars in China
  • Table 5.23: Major biosimilar manufacturers in China
  • Table 5.24: Top 60 Chinese-Owned Biopharmaceutical Companies (Part 1)
  • Table 5.25: Top 60 Chinese-Owned Biopharmaceutical Companies (Part 2)
  • Table 5.26: Top 60 Chinese-Owned Biopharmaceutical Companies (Part 3)
  • Table 5.27: Major biosimilar manufactures based in India
  • Table 5.28: Major Biosimilars and Manufacturers in India