Biosimilars
Manufacturing: Key
Considerations and
Expected Outsourcing
Practices (2015)
Info@ISRreports.com
©2015 In...
www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2...
www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2...
www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2...
www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2...
www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2...
www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2...
www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2...
of 8

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. Learn mo
Published on: Mar 4, 2016
Published in: Health & Medicine      
Source: www.slideshare.net


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

  • 1. Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2015) Info@ISRreports.com ©2015 Industry Standard Research www.ISRreports.com PREVIEW
  • 2. www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2015) 2 act with confidence Report Overview 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. 28 Charts and Graphs 33 Pages Q2, 2015 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 Report Structure: NEXT: Table of Contents and Sample Pages
  • 3. www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2015) 3 act with confidence Table of Contents For full table of contents and additional sample pages, please download the full preview: http://bit.ly/cmobio
  • 4. www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2015) 4 act with confidence act with confidence Introduction www.ISRreports.com ©2015 | Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2015) 4 Introduction It has been nearly a decade since the EU released its first “Guideline on similar biologic medicinal products” in October 2005� How far has the industry come in terms of producing biosimilar products? Let’s just say it is a rapidly maturing industry, at least from the manufacturer standpoint� Previous ISR market research into the biosimilar environment reveals that physicians, pharmacists, and patients have very little knowledge about biosimilars and some have a healthy dose of skepticism� However, the biosimilar train marches on and with inevitable patent expiries, pharma has been busy gearing up for the predicted boom in the biosimilar market� The industry wants to be well-positioned when the anticipated growth in biosimilars arrives� March of 2015 marked the FDA’s first approval of a biosimilar (Sandoz’s Zarxio, a biosimilar for filgrastim—Amgen’s Neupogen) and is a sign that the anticipated growth spurt is getting closer� Pharma companies, CMOs, and CROs are continuing to develop partnerships centered on biosimilar development� In early 2015, Pfenex and Hospira formed an agreement to develop and commercialize Genentech’s Lucentis� In fact, Hospira’s biosimilar pipeline was cited as a factor in Pfizer’s proposed acquisition of the company� While much of the industry’s buzz around biosimilars is focused on pricing levels, patient uptake, payer reimbursement levels, and regulatory approval pathways, few have discussed, perhaps, one of the most important aspects of biosimilars; manufacturing� These are not “simple” chemical generics to be produced� Rather, manufacturing these complex products will be a critical component of successfully commercializing biosimilars, in terms of achieving both regulatory approvals as well as cost efficiencies� Participants in this study believe that manufacturing products within the accepted bioequivalence range and maintaining consistency in manufacturing processes will be two key challenges associated with the commercial manufacture of biosimilars� In ISR’s Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2015) report, commercial manufacturing decision-makers share their perspectives on biosimilars manufacturing topics such as how much commercial manufacturing is expected to be outsourced, their comfort outsourcing to particular CMOs, and their companies’ outlooks on manufacturing and selling biosimilar products� Sample Page
  • 5. www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2015) 5 act with confidence act with confidence Study Data www.ISRreports.com ©2015 | Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2015) 11 Biosimilar manufacturing: in- house vs� outsourced The majority of respondents, 71%, indicated their business uses a combination of in- house and outsourced manufacturing for their large molecule products� “How does your company currently manufacture your portfolio of large molecule products?” (Base = 69 - respondents whose companies currently market/sell large molecule products) www.isrreports.com  ©2015|  2015  Biosimilars  Manufacturing  Key  Considerations  and  Expected  Outsourcing  Practices        10             Biosimilar manufacturing: in-house vs. outsourced The majority of respondents, 71%, indicated their business uses a combination of in- house and outsourced manufacturing for their large molecule products. “How does your company currently manufacture your portfolio of large molecule products?” (Base = 69 - respondents whose companies currently market/sell large molecule products) 26% 71% 3% All large molecule products are manufactured completely in-house Some manufacturing processes for large molecule products are done in- house and some are done using Contract Manufacturing Organizations All large molecule products are manufactured completely using Contract Manufacturing Organizations © ISR Reports 2015 Sample Page
  • 6. www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2015) 6 act with confidence Sample Page For full table of contents and additional sample pages, please download the full preview: http://bit.ly/cmobio
  • 7. www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2015) 7 act with confidence Ordering Information Industry Standard Research (ISR) is the premier, full service market research provider to the pharma and pharma services indus- tries.  With over a decade of experience in the industry, ISR delivers an unmatched level of domain expertise.    For more information about our off-the-shelf intelligence and custom research offerings, please visit our website at www.ISRreports.com, email info@ISRreports.com, or follow us on twitter @ISRreports. About Industry Standard Research Save on this, or any ISR report, by registering a free account Register now • Receive a $250 instant credit towards any ISR report • Earn 10% credit towards all future purchases • Receive advanced notifications on ISR’s latest reports and free resources For pricing and ordering information, please visit: http://bit.ly/cmobio
  • 8. www.ISRreports.com ©2015 | Preview of: Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (2015) 8 act with confidence www.ISRreports.com ©2013 | Preview of: Benchmarking the Pharma Industry’s HEOR Functions 8 act with confidence

Related Documents