Newsletter | September 12, 2019

09.12.19 -- Is It Time To Change The Biosimilar Regulatory Paradigm?

Featured Editorial
A Second Reformation: Returning Biosimilar Regulations To Scientific Roots
By Anna Rose Welch, editor, Biosimilar Development

In light of a recent publication in BioDrugs, I spoke with one of the authors to learn more about the "Confirmation of Sufficient Likeness" and the scientific evidence that has informed this proposed regulatory paradigm shift away from “Totality of Evidence.”

4 (More) Critical Considerations For Drug Delivery Device Development
By Michael Song, Ph.D.

This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.

Is It Time To Throw In The Towel On Biosimilars In The U.S.?
By Rob Wright, chief editor, Life Science Leader

Rob Wright takes issue with Peter Bach, M.D., and Mark Trusheim’s recommendation that the U.S. would be better served by abandoning continued biosimilar drug development.

Industry Insights
The How And Why Of Normalizing Your Western Blots
Article | By Laurelle Turner and Kenneth Oh, Bio-Rad Laboratories, Inc.

How normalization can help you be confident that your data is not being skewed by experimental errors.

Achieving Operational Efficiency In Today’s Fragmented Market
Article | By Joseph Makowiecki and Madhu Raghunathan, GE Healthcare Life Sciences

Meeting the goals of today’s industry requires a deeper look at how to continuously achieve maximum utilization and reduce waste without sacrificing quality in the race to be first to market. 

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