Newsletter | March 24, 2016

03.24.16 -- How Can China Benefit Biosimilar Development?

Biosimilar Development
Featured Editorial
Will China Emerge As A Biosimilar-Development Hub?
By Anna Rose Welch, Editor, Biosimilar Development   By Anna Rose Welch, Editor, Biosimilar Development
As the global biosimilar market continues to grow, biotechs — small, medium, and large — are looking to biosimilars as a new and promising business opportunity. As Gerry McGettigan, COO of amp biosimilars AG (ampb), discusses, China offers a number of benefits for those building a biosimilar business.
GxP-Regulated Firms And The Importance Of Data Integrity
By Louis Garguilo, Editor, Outsourced Pharma   By Barbara W. Unger, Unger Consulting Inc.
Regulatory agencies have cited deficiencies in GMP data integrity and data management for at least the past 15 years. Yet it appears that the industry has made limited progress in recognizing and remediating these deficiencies. How did we arrive at this point where data integrity is such a significant focus, and how can companies begin to address these challenges?
Biophysical Analysis And The Development Of Follow-On Biologics
By Christopher Sucato and Mario DiPaola, Blue Stream Laboratories, Inc.   By Christopher Sucato and Mario DiPaola, Blue Stream Laboratories, Inc.
Like small molecule generics, biosimilars can lower costs for lifesaving therapies. But they must have an efficient and well-developed characterization platform in order to deliver on economic savings. There are several biophysical techniques that must be part of any biosimilar’s analytical characterization platform.
News Headlines
Celltrion: Switching To Remsimaâ–¼ (infliximab) From Originator Has No Negative Effect On Safety Or Efficacy
GPhA Urges Senate To Stop Abuse Of Restricted Distribution Agreements
BIO And Kentucky Life Sciences Council Support Bill Ensuring Patient Access To Interchangeable Biologic Medicines
mAbxience And UCAB Announce Collaboration To Develop A Biosimilar Aimed At Preventing RSV
Biosimilars Blog
  Read this week’s blog posts on:
• Eli Lilly, Samsung Bioepis Meeting Stirs Up Partnership Rumors
• Would FDA $82M Biosimilar Workload Be Helped By New Bill?
• FDA Releases New Interpretation Of BPCIA
• Could Biosimilar Companies Be Facing New Financial Challenge?

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