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

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

Table Of Contents

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

Copyright and Usage Guidelines .3
Introduction ..4
Methodology ..5
Summary Respondent Demographics ...6
Participant years of industry experience .6
Participant geography .6
Participant company size ...6
Study Data ..7
Biosimilar familiarity .8
Large molecule products offering 9
Large vs. small molecule outsourcing ...10
Biosimilar manufacturing: in-house vs. outsourced ...11
Stance on selling biosimilars 12
Stance on manufacturing biosimilars 13
Bioprocessing equipment 14
Outsourced biosimilars manufacturing activities ...15
Primary biosimilar outsourcing drivers ..16
Biosimilar manufacturing, by geography ..17
Biosimilar outsourcing comfort, by company .18
Most difficult aspect of biosimilar manufacturing, unprompted .19
Price as a driver for switching behavior ..20
Respondent Demographics .21
Company type 22
Decision making responsibility ...23
Primary area of decision making responsibility ...24
Outsourcing influence ..25
Commercial manufacturing responsibilities 26
Job title 27
Involvement in manufacturing process 28
Headquarters location ..29
Office location 30
Commercial manufacturing activity involvement ...31
Years of industry experience ...32
About Industry Standard Research ...33

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