Newsletter | May 16, 2019

05.16.19 -- The Purple Book: A Challenge For FDA, Biosimilar Makers?

 
Sponsor
  Biologic Sterile Injectable Drug Product Manufacturing Market Overview And Outlook
 

This market research report provides an overview of the current biologic sterile injectable market dynamics as well as what our survey respondents — all outsourcing decision makers — predict the market will look like in 2022. Key statistics include development-stage and marketed product volume, the proportion outsourced, and the number of CMOs required to complete the work. You can purchase the report or download a free preview by clicking here.

Featured Editorial
How Advocacy Groups, Biosimilar Makers Can Improve Physician Education
 
By Anna Rose Welch, editor, Biosimilar Development

An advocate from the Crohn's and Colitis Foundation shares details about the Foundation’s ongoing initiatives in terms of educating physicians, as well as what can be done to better understand and improve physicians’ biologics and biosimilar prescribing practices.    

How The Purple Book Continuity Act Could Challenge Biosimilars And The FDA
 
By Kate Cook, Greenleaf Health

On March 5, 2019, Representative Anna Eshoo (D-CA) introduced H.R. 1520, the “Purple Book Continuity Act of 2019.” Recognizing that the Purple Book provides useful information to sponsors of biosimilar products — and that additional information may be even more useful — this bill would create new requirements for the FDA. 

Industry Insights
A Common-Sense Approach To Sustainability In The Biosimilar Business
White Paper | By Ashok Kumar, president, Centre for Research & Development, IPCA

Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.

Improved Process Economics Of HUMIRA Biosimilar Purification
Application Note | By Randy Drevland, et.al., Bio-Rad Laboratories, Inc.

This application note proposes an alternate but equally effective approach to biosimilar purification, by substituting a less-expensive ion exchange resin for the affinity capture step.

Sponsor
  10th Annual Summit On Biosimilars
 

June 24 and 25, 2019 | New York, NY

Network with and discuss the future of biosimilars with leaders from both innovator and biosimilar companies at the industry’s leading event directed to the legal, regulatory, and commercial aspects of the biosimilars marketplace. Be in the room as solutions are formulated to the complex regulatory and patent challenges ahead. Use our exclusive discount code for 10% off: P10-999-BIO19.

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