Newsletter | January 9, 2020

01.09.20 -- The Top 7 Biosimilar Developments of 2019

 
Featured Editorial
The Top 7 Biosimilar Developments Of 2019
 
By Anna Rose Welch, editor, Biosimilar Development

I normally only do the top five developments for the biosimilar industry in this annual column. But it turned out, upon reflection, that 2019 was an even more eventful year than it may have seemed as we were making our way through it. So, you’re getting a whopping seven this year.

Biosimilar Competition Is Here To Stay In 2020
 
By Anna Rose Welch, editor, Biosimilar Development

Following Peter Bach’s controversial argument to “throw in the towel” on biosimilars, I reached out to three economic experts for their perspectives on how to create a functioning, competitive biologics marketplace and which economic and government policies will be the best to pursue for long-term success.

What Does 2020 Hold For Biosimilars? Industry Experts Weigh In
 
By Anna Rose Welch, editor, Biosimilar Development

As we face 2020, several big questions remain from the past year and about what the future may (or may not) bring for the industry. Here, these 19 experts pose their biggest questions for the new year, as well as how they anticipate or hope these questions could be answered.

Biosimilars: Lessons Learned From Regulatory Approvals
 
By Sarfaraz K. Niazi, Ph.D., and Sunitha Lokesh

This article, based on the EMA’s European public assessment reports (EPARs) and the FDA’s BLA (biologics license application) reviews, identifies many inconsistencies that require revision of regulatory guidance to ensure faster approval of biosimilars.

Industry Insights
Chromatography Resin Alternative For Capture Purification Of Antibodies
Application Note | By Payal Khandelwal and Mark Snyder, Bio-Rad Laboratories, Inc.

Protein A affinity purification has multiple limitations in terms of productivity at manufacturing scale and the costs associated with making commercial antibodies, especially biosimilars. 

Modular Bioprocessing Alleviates Drug Manufacturing Woes
Case Study | GE Healthcare Life Sciences

Building a bioprocessing facility is usually a complicated process and requires partnering, not only with drug developers, but also with many different experts in various industries.

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