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Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2015)

  • June 2015
  • 33 pages
  • Industry Standard Research
Report ID: 3558651

Summary

Table of Contents

Almost ten years after the EU released its first “Guideline on similar biologic medicinal products,” the US FDA has given its first approval of a biosimilar. The anticipated growth spurt in the development and manufacture of biosimilars has never been closer, and both biopharmaceutical companies and contract manufacturers want to be well-positioned to capture a share of this growing industry segment. ISR’s research into the biosimilar environment will inform readers of current knowledge and skepticism surrounding these products, including biopharmaceutical companies’ outlooks on manufacturing and selling biosimilars, comfort levels in outsourcing biosimilar manufacturing and which contract manufacturers are likely to be considered for the work.

Almost ten years after the EU released its first “Guideline on similar biologic medicinal products,” the US FDA has given its first approval of a biosimilar. The anticipated growth spurt in the development and manufacture of biosimilars has never been closer, and both biopharmaceutical companies and contract manufacturers want to be well-positioned to capture a share of this growing industry segment. ISR’s research into the biosimilar environment will inform readers of current knowledge and skepticism surrounding these products, including biopharmaceutical companies’ outlooks on manufacturing and selling biosimilars, comfort levels in outsourcing biosimilar manufacturing and which contract manufacturers are likely to be considered for the work.

Publication Date
1. Introduction
2. Methodology
3. Study Data
4. Respondent Demographics
5. About Industry Standard Research

How you can use this report:

Manufacturers
- Stay on top of industry trends by learning what biopharmaceutical companies currently manufacturing large molecules think the future holds for biosimilar manufacturing
- Learn what methods of biosimilar manufacturing peers are gravitating towards
- Understand where, geographically, biopharmaceutical companies are looking to manufacturer biosimilars CMOs
- Start to understand the market potential for outsourced biosimilar manufacturing
- Learn what biopharmaceutical companies would value from a CMO and leverage these drivers in your sales and marketing efforts
- Get an early indication of market leaders by knowing which manufacturers and CMOs respondents would be most comfortable using for biosimilar production

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ref:plp2015

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