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.
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?
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.
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?