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


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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.

For 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

For 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

1. Introduction

2. Methodology

3. Study Data

4. Respondent Demographics

5. About Industry Standard Research

ISR understands that you’re looking for confidence in your market research. With ISR, you’ll consistently receive

  • Focused Domain Expertise — We’ve operated in pharmaceuticals for over 15 years and because it’s our sole focus, our domain expertise brings value to the work that “generalist” researchers can’t deliver.
  • Genuine Research Expertise — Our market research experience has developed over 20 years in many dynamic industries.  We capture appropriate sample sizes, given the research objectives, and we use appropriately sophisticated statistics to uncover everything that’s real and to give you confidence in your decisions. Read our Six Questions to Ask About Your Market Research to learn more about why our industry expertise sets us apart.
  • Transparency — If you’re like many, you’ve been disappointed more than once by research providers who fail to live up to their promises, providing you with their “professional judgment” in place of sound data; and suspect contacts instead of real decision-makers. We deliver the beliefs, attitudes, and intentions of people who matter – and we’ll prove it by showing you the titles of your respondents.

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