Newsletter | February 25, 2016

02.25.16 -- Should FDA Be Solely To Blame For Slow BPCIA Formation?

Biosimilar Development
Featured Editorial
Should FDA Be Solely To Blame For Slow BPCIA Formation?
By Anna Rose Welch, Editor, Biosimilar Development   By Anna Rose Welch, Editor, Biosimilar Development
In a recent hearing on the implementation of the BPCIA, a lack of funding was pinpointed as a cause for the slow formation of the biosimilar approval pathway. While this is a likely scenario, this hearing continued to emphasize the overall lack of transparency over what else might be stalling the development of this pathway five years after the approval of the BPCIA.
UPS Pain In The Chain Survey: Pharma Makes Gains In Compliance, Partnerships
By Ed Miseta, Editor, Clinical Leader   By Ed Miseta, Editor, Clinical Leader
UPS's Pain in the Chain survey is one of the best ways to understand where life sciences companies stand on the issues making logistics a headache and keeping executives up at night. Since 2008, the survey of healthcare and life sciences supply chain professionals has attempted to determine the needs of these companies.
  At the Biosimilars Clinical Studies And Analytical Similarity Summit we’ll be providing key insights from thought leaders into the biggest challenges in the analytical and clinical phases of biosimilar drug development, from responding to additional regulatory challenges, demonstrating the quality attributes needed to prove interchangeability and successfully execute cost-efficient clinical trials.

Explore the program agenda here.
News Headlines
Moody's: Growing Biosimilar Pipelines Pose Long-Term Threat To Branded Pharma Companies
Biosimilars Council Statement Regarding The World Health Organization's Biosimilar Naming Proposal
Biosimilars Blog
  Read this week’s blog posts on:
• FDA Launches Biosimilar Education Course
• Celltrion Seeing Financial Success From Biosimilars
• Sandoz Calls On Supreme Court For BPCIA Decision

For these and other headlines, click here.
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