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市場調查報告書
印度的生物仿製藥
Biosimilars: India Update
| 出版商 |
Datamonitor |
| 出版日期 |
2011年10月 |
商品編碼 |
229415 |
| 內容資訊 |
英文 Pages: 51 |
| 價格 |
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印度的生物仿製藥 是由出版商Datamonitor在2011年10月所出版的。
這份英文市場調查報告書包含Pages: 51 價格從美金1900起跳。
現在在印度，包含革新性的複製版在內的所有生物製劑都被承認為新藥。但是2011年7月中印度的生物科技局在等待來自印度醫藥品法規當局的生物仿製藥臨床實驗指令案的狀況下、做成類似生物製劑的前臨床的評價之短縮手續草案。
本報告書為印度的生物製劑法規、對印度街受生物製劑的主要發展/阻礙要因、印度國内所開發的主要市售/管道生物製劑、主要生物製劑業者與他們所實行的戰略等詳細調査・分析，概述如下。
第1章 總綱
- 導論
- 戰略的調査範圍與焦點
- 主要結果
- 生物製劑法規概要
- 生物製劑受到的的發展/阻礙要因
- 市售/管道生物製劑
- 印度市場之生物製劑的主要業者
- 相關報告書
第2章 印度：生物製劑法規概要
- 印度做成類似生物製劑的前臨床評價草案
- 印度的生物製劑之承認
- 主要承認機關
- 印度之生物製劑的主要法規
- 生物製劑之承認
第3章 印度：生物製劑受到的的發展/阻礙要因
- 印度的生物製劑受到的的發展要因
- 印度不完全的專利施行為國内生物製劑製造商帶來機會
- 不怎麼嚴苛的法規要件與R&D的低成本促進了複製版生物製劑的發展
- 印度國内生物製劑比起先發品來價格都比較低
- 針對參加支援印度/世界市場生物製劑開發合作的國内企業
- 公家/民間部門的合作促進了印度的生物技術開發
- 印度的生物製劑受到的阻礙要因
- 低水準的健康保險限制對於生物製劑的接近
- 對國内製造的安全性問題的接受度會成為可能的阻礙因素
第4章 印度：市售/管道生物製劑
第5章 印度：生物製劑的主要業者
第6章 參考文獻
- 刊行物與網路記事
- 參加會議
- Datamonitor報告書
第7章 附錄
Description
Introduction
Currently, all biologics in India, including innovative and copy biologics are approved as new drugs. However, in July 2011, the Department of Biotechnology proposed draft guidance outlining an abridged procedure for the preclinical evaluation of similar biologics in India, with the DBT currently awaiting draft guidance on clinical trials for biosimilars from the Drug Controller General of India.
Features and benefits
- An overview of biologic regulations in India
- Insight into the key drivers and resistors to biologic uptake in the India
- Assessment of the key marketed and pipelines domestically developed biologics in India
- Provides a snapshot of key major biologic players and the strategies they have implemented
Highlights
- Due to limited R&D capabilities in terms of finance and expertise, most domestic biopharmaceutical companies have focused on manufacturing simple copy biologics, and as a result the simple biologic market is highly competitive, resulting in significant downward pressure on pricing.
- A number of manufacturers are now developing more complicated second-generation copy biologics such as PEGylated versions of erythropoietin and filgrastim and monoclonal antibodies, which though more expensive and complex to develop, can be priced at a premium, and compete in a much less crowded market than that faced by first-generation biologics.
- Despite the low price of copy biologics compared to originator brands, the domestic market is restricted by limited health insurance coverage and therefore poor access to biologic drugs. Also, issues regarding the quality and safety of some domestically manufactured biologics remain a concern among patients and physicians.
Your key questions answered
- Evaluate the evolving copy biologics market, the drivers and resistors to uptake, and future opportunities for domestic players in India.
- Gain insight into the strategies employed by copy biologic producers seeking to enter or expand their presence in the Indian market place.
TOC
Executive Summary
- Introduction
- Strategic scoping and focus
- Datamonitor key findings
- Biologic regulatory overview
- Drivers and resistors for biologics uptake
- Marketed and pipeline biologics
- Key biologic players in the Indian market
- Related reports
INDIA - BIOLOGIC REGULATORY OVERVIEW
- India issues draft guidelines for preclinical evaluation of similar biologics
- Key requirements for similar biologics
- Approval of biologic drugs in India
- Key approval bodies
- Major rules governing biologics in India
- Biologic drug approval
INDIA - DRIVERS AND RESISTORS OF BIOLOGIC UPTAKE
- Drivers of biologic uptake in India
- Poor patent enforcement in India provides opportunities for domestic biologics manufacturers
- Less stringent regulatory requirements and low R&D costs promote copy biologics development
- Domestic biologics are priced much lower in India compared to originators
- Domestic companies enter partnerships to facilitate biologic development for the Indian and global market
- Public-private sector partnerships drive biotech development in India
- Resistors to of biologic uptake in India
- Low levels of health insurance limit access to biologic drugs
- Safety concerns over domestically manufactured biologics might impede their uptake
INDIA - MARKETED AND PIPELINE BIOLOGICS
- Biologic sales in India
- Marketed biologics in India
- Second-generation biologics
- Monoclonal antibodies
INDIA - KEY BIOLOGICS PLAYERS
- Biocon
- Dr. Reddy's
- Intas Biopharmaceuticals
- Reliance Life Sciences
- Zydus Cadila
BIBLIOGRAPHY
- Publications and online articles
- Conferences attended
- Datamonitor reports
APPENDIX
- Exchange rates used in this report
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