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BIOSIMILARS: BUSINESS REVIEW

BIOSIMILARS BUSINESS REVIEW

出版商 Fitch Solutions, Inc. 商品編碼 53703
出版日期 4 Issues/Year 內容資訊 英文
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BIOSIMILARS: BUSINESS REVIEW BIOSIMILARS BUSINESS REVIEW
出版日期: 4 Issues/Year 內容資訊: 英文
簡介
此商務通訊中,彙整了關於每個四半期的Biosimilars相關企業製品開發•R&D動向、合約動向、財務業績、市場戰略、其他各種發表。此外,內容還涵蓋了政府•監督機關的政策、提倡、申請認證、各國市場動向、企業概況等。報告書之內容摘要如下所示。

目次範例

要點

  • EC、Hospira以及Stada的EPO Biosimilars認證
  • Henry Waxman:關於美國資料獨占性的課題消解
  • Ranbaxy:追求大部分的Zenotech
  • 西班牙:生物製劑替代品的排除

說明

企業評論

  • 3SBio:第3四半期•2007年9個月的銷售發表
  • Abraxis:Green Cross與Biosimilars的合約
  • Avesthagen/Cipla:Siegfried的合併
  • Biocon:經口胰島素製品的階段I成果發表
  • BioGeneriX•Neose Technologies:GlycoPEG-GCSF階段I的2件研究之良性成果發表
  • Biopartners:與Medical House的Valtropin Delivery System Collaboration消解
  • Bioton:2007年第3四半期財務成績發表
  • Bogin:舉辦Biosimilars的圓桌會議
  • Cipla:提示Biosimilars計畫的建議
  • Dragon:變賣EPO企業後從Biosimilars部門撤退、等

革新者評論

  • Amgen:Biosimilars的EPO前景協議
  • Biogen Idec:鎖定變賣對象的失敗
  • Roche:取得Mircera的FDA認證
目錄

A quarterly review that will help you navigate through the twists and turns of the emerging biosimilar market.

A business review of, and commentary on, the developments that are shaping this rapidly evolving and often contentious sector of the generic drug industry.

Few areas of the generics market are proving as troublesome to develop as biosimilars. Unable to replicate reference products in the usual manner, companies are grappling with both production issues and regionally variable regulatory demands.

Whereas the EU has outlined a settled policy and regulatory pathway, the USA is at a far earlier stage. The FDA has proved unwilling to act without legislation in Congress, which is only in 2007 appearing as a practical proposition.

But these issues must be resolved. The number of biotech-based products coming off patent will increase steadily; indeed, the time may not be far off when almost all newly-developed drugs are biologics, not small-molecule chemicals.

Industry executives, regulators and commercial management operating in or monitoring this developing sector need to stay in close touch and, more importantly, be able to assess the significance of developments in a broader industry context.

That is why Espicom Business Intelligence, the leading provider of generic drug business data, has launched BIOSIMILARS. This well written quarterly review will help you navigate through the twists and turns of the emerging biosimilar market. Packed with the latest industry and regulatory developments, company profiles and keen insightful commentary, it is essential reading for everyone involved or interested in biosimilars.

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