本報告已在2011年07月19日停止出版。
生物藥劑佔全球醫藥品市場的10 ∼15 ％ ，光是美國就佔了約 300 億美金。但是生技學名藥的開發還殘留著幾個重要的問題等待解決。
在醫療儀器、醫藥品市場上專門提供具有權威情報的市調公司Espicom Business Intelligence（總公司：英國），調查與分析生技學名藥市場的動向，並有系統地出版綜合報告書 “Biogenerics 2005: an emerging global market? - 2nd Edition” 。
此報告書使用圖表在內的篇幅，除了說明對於參與生技學名藥市場的障礙、影響開發的政治因素，也探討英國及歐洲的規範動向、最近被認可的實例等。此報告書的概略架構如下所示。
摘要
美國生技學名藥市場
- Hatch Waxman 規章不適合生物藥劑
- 例外
- FDA 把有關生物藥劑的責任移交給醫藥品評價中心(CDER )
- 505 (b) (2) 途徑是否妥當
- 不行簡略申請是否比較簡單
- 參議院公聽會 2004 年 6 月
- Amgen 的證詞
- GPhA 的證詞
- FDA 的證詞
- 平行貿易問題
- 結論
EU 生技學名藥市場
- EU 的新認可過程
- 對於柯斯生物藥劑（biosimilars）的規章
- EMEA 的指導方針文件
- Omnitrope
- 專利的保護及資料管理
- EU 嘗試單獨專利的失敗
可製成生技學名藥品的藥劑
- 紅血球生成素（EPO）
- 人類生長激素（hGH、somatropin）
- G-CSF / GM-CSF
- 重組性胰島素
- 干擾素(Interferon)
製造商檔案（23家）
- Anhui Anke Biotech
- Biocon
- BioGeneriX
- BioPartners
- Cangene
- CIGB (Cuba)
- Cipla
- CheilJedang (CJ Corp)
- Dr Reddy’s
- Dragon Pharmaceuticals
- GeneMedix
- Inno Biologics
- LG Life Sciences
- Microbix
- Momenta Pharmaceuticals
- Pliva
- Sandoz
- Savient Pharmaceuticals
- Shenzhen Kexing Biotech
- Shenyang Sunshine Pharmaceutical Co Ltd
- Stada Arzneimittel
- Teva Pharmaceuticals
- Wockhardt
附錄
There are potentially big rewards for companies who can overcome the regulatory, legal and technical obstacles related to biogenerics. But there are dangers too - that is why this critical, analysis is essential reading.
Biological drugs account for 10-15% of the world pharmaceutical market. This is equal to around US$30 billion in the USA alone. The biologicals sector is outperforming the pharmaceutical industry as a whole, growing at double the pace in some cases. But the development of the biogenerics sector will only come after some significant problems have been tackled.
CONSIDER...
Biologic drugs are expensive and increasingly widely-used. For chemical drugs, generic versions of off-patent products have helped to reduce pharmacy bills and increase funding for new products. It would seem obvious, therefore, for companies to develop generic versions of the older biologic drugs, and for health payers to welcome them. But achieving this has proved far from straightforward. Early market entry in the USA is not a practical proposition. The nature of the current regulatory system precludes approval in most cases. The FDA has yet to issue detailed guidance on the topic, although this is planned for 2005. Only then can Congress begin the legislative process. Given the time this will probably take, biogenerics are unlikely to appear on the US market until at least 2010. The European Union is some years ahead of the USA, on paper at least. The 2003 EU regulatory reforms make specific provision for biogenerics, and the EMEA has issued guidance documents on most of
the major products. No product has yet been approved in the EU, however, with a number of companies still preparing regulatory submissions. Market entry in two to three years is a realistic prospect.
This key report answers the important questions
For everyone involved in this emerging market sector Biogenerics 2005: An Emerging Global Market? (published September 2005) is essential reading. Thoroughly researched and including the very latest information, the report distils and analyses the key issues in more than 100 thought-provoking pages:
- What are the regulatory hurdles to be overcome?
- How might the political environment affect development?
- How might companies overcome technical issues related to, for example, bioequivalence?
- US/Europe regulation: USA in the slow lane but for how long?
- What products have recently been approved and which are under consideration?
- Where are the best opportunities?
- The commercial/competitive cost of biogenerics: when is it worth it?
Report Contents
- Executive summary
- The biogeneric market environment in the USA
- The biogeneric market environment in the EU
- Products under consideration
- Biogenerics manufacturers profiles
- Market data
Whats in a name?
This report uses the term "biogenerics" to describe unbranded off-patent biological products. Others use
- Biosimilars
- Follow-on biologicals
- Second-generation biological
- Whatever the name, the issues are the same!
TABLE OF CONTENTS
FOREWORD
EXECUTIVE SUMMARY
- What is a biologic drug?
- What is a biogeneric?
- Why are biogenerics an issue?
- Growth of US pharmaceutical expenditure
- Obstacles
- Political
- Regulatory
- Scientific
- USP publishes monographs on somatropin
- Comparability; branded industry precedent?
- Immunogenicity
- Legal
- Patent challenges
- Exclusivity of test data
- Commercial
- Will the cost of getting a biogeneric approved make it financially worthwhile?
- Threat of authorised generics
- Obsolescence of older products
- Cultural
- Regional Market Prospects
- USA
- Canada
- EU
- Australia
- Japan
- China
- Other ess-regulated markets
- Manufacturing Overview
- USA
- Canada
- Europe
- India
- China
- Korea
- Cuba
BIOGENERIC MARKET ENVIRONMENT IN THE USA
- Hatch Waxman is not applicable to biologics
- Exceptions?
- FDA transfer of biologic responsibility to CDER
- Is the 505(b)(2) route feasible?
- BIO Citizen Petition against 505(b)(2)
- Omnitrope 505(b)(2) submission
- Genentech Citizen Petition against 505(b)(2)
- Pfizer Citizen Petition against approval of Omnitrope
- Easier not to seek an abridged application?
- Senate Hearing, June 2004
- Amgen testimony
- GPhA testimony
- FDA testimony
- Parallel trade issues
- Conclusion
BIOGENERIC MARKET ENVIRONMENT IN THE EUROPEAN UNION
- The new EU approval process
- Regulation of biosimilars
- 2005 EMEA Guideline Documents
- EPO
- G-CSF
- Somatropin
- rH Insulin
- Omnitrope
- Patent protection/data exclusivity
- New Bolar provision
- Attempt to create a single EU Patent fails
LIKELY BIOGENERIC PRODUCTS
- English Biologic Prescription Data, 2003-04
- Erythropoietin (EPO)
- PRCA incidence
- Procrit/Eprex
- Epogen/Aranesp
- Neorecormon/Epogin
- Epogin
- Biogeneric versions
- Human Growth Hormone (hGH, somatropin)
- Genotropin .
- Humatrope
- Norditropin/other Novo Nordisk hGH products
- Nutropin/other Genentech hGH products
- Saizen/Serostim
- Biogeneric versions
- G-CSF/GM-CSF
- Neupogen/Neulasta
- Neutrogin/Granocyte
- Leukine
- Biogeneric versions
- Recombinant insulin
- Novo Nordisk recombinant insulin products
- Eli Lilly recombinant insulin products
- Aventis recombinant insulin product: Lantus
- Biogeneric versions
- Interferon
- Schering Plough Interferon A (Intron A range)
- Roche Interferon A range (Roferon/Pegasys)
- Betaseron/Betaferon
- Avonex
- Rebif
- Biogeneric versions
MANUFACTURER PROFILES
- Anhui Anke Biotech
- Biocon
- BioGeneriX
- Cangene
- Neose Technologies
- BioPartners
- Cangene
- CIGB (Cuba)
- Cipla
- CheilJedang (CJ Corp)
- Dr Reddy s
- Dragon Pharmaceuticals
- Merger with Oriental Wave Holdings
- EPO
- G-CSF
- Sales data
- GeneMedix
- Inno Biologics
- LG Life Sciences
- Microbix
- Momenta Pharmaceuticals
- Pliva
- EPO, Croatian approval granted
- G-CSF, agreement with Barr Laboratories
- Mayne Pharma
- Sandoz
- Lek
- Sandoz biotech plants, Austria
- Lek biotech plant, Slovenia
- Savient Pharmaceuticals
- Savient Sells Biologics Division to Ferring
- Shenyang Sunshine Pharmaceutical Co Ltd
- Shenzhen Kexing Biotech
- Stada Arzneimittel
- Teva Pharmaceuticals
- Tev Tropin
- Sicor
- Tianjin Hualida Biotechnology Pharmaceutical Co
- Wockhardt
APPENDIX: GENERIC MARKET DATA
SOURCES
DIRECTORY
- Regulators
- Industry Associations
- Manufacturers
INDEX OF TABLES
- US Research-Based Pharmaceutical Manufacturers Sales, 1990-2004 (US$ millions)
- Pharmaceutical Expenditure as % of GDP, 1990-2004
- Growth of Medicaid Pharmaceutical Expenditure, 1997-2003 (US$ millions)
- Major Countries where Biogenerics are Currently Marketed
- Biogeneric Products Developed/Under Development by Company
- Biogeneric Products Marketed by Company
- Summary Branded Sales Data for Leading Biotech Products, 2001-04 (US$ millions)
- Summary Branded Sales Data for leading Biotech Products, 2002-04 (% Change)
- J&J Sales of Procrit/Eprex, 2001-2004 (US$ millions)
- Amgen Sales of Epogen/Aranesp, 2001-2004 (US$ billions)
- Roche Sales of Neorecormon/Epogin, 2002-2004 (SwF millions)
- Epogin Sales in Japan, 2002-03 (\ billion)
- Genotropin Sales, 2001-04 (US$ millions)
- Humatrope Sales, 2001-04 (US$ millions)
- Novo Nordisk hGH Sales, 2001-04 (DKK millions)
- Genentech hGH Sales, 2001-04 (US$ millions)
- Serono hGH Sales, 2001-2004 (US$ millions)
- Neupogen/Neulasta Sales, 2001-04 (US$ billions)
- Sales of Neutrogin/Granocyte, 2002-04 (billion yen)
- Sales of Insulin Analogues, 2001-2004 (DKK million)
- Sales of Humulin and Humalog, 2001-2004 (US$000s)
- Sales of Lantus, 2001-2004 (euro millions)
- Sales of Intron A (including PEG-Intron), 2001-2004 (US$ millions)
- Sales of Pegasys, 2002-04 (SwF millions)
- Sales of Betaseron/Betaferon, 2001-04 (euro millions)
- Sales of Avonex, 2001-04 (US$ millions)
- Sales of Rebif, 2001-04 (US$ millions)
- Dragon Pharmaceutical revenues, 2003-04 (US$ millions)
- Dragon Pharmaceutical revenues by Segment, Q1 2005 (US$ millions)
- Countries by Population (millions)
- GDP per capita, US$
- Health Expenditure per capita (US$)
- Health Expenditure as % of GDP
- Hospital Beds per 000 Population
- Physicians per 000 Population
- Total Pharmaceutical Market, (US$ billions)
- Total Pharmaceutical Expenditure Per Capita, (US$)
- Generic Pharmaceutical Markets (US$ millions)
- Generic Pharmaceutical Expenditure per capita, (US$)
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