Newsletter | January 2, 2020

01.02.20 -- Biosimilar Experts Highlight 2019 Triumphs, Tribulations

 
Featured Editorial
Can The FDA Salvage Interchangeable Follow-On Biologics?
 
By S. Ropka, T. Mathias, and M. Divelbiss, Axinn, Veltrop & Harkrider LLP

Learn the statutory and regulatory requirements for the interchangeability designation, how the designation hampers follow-on biologics, and why the FDA should loosen requirements for the designation.

The Biologic, Biosimilar Insulin Transition: The Patient Perspective
 
By Anna Rose Welch, editor, Biosimilar Development

In this article, a patient advocate from the JDRF shares the diabetes community’s perspective on the upcoming regulatory transition of insulins and how the industry can better engage and educate patients about the future presence of insulin biosimilars.

Transition Biologics: FDA, Industry Examine Regulatory Nuances
 
By Anna Rose Welch, editor, Biosimilar Development

Though these experts all believe this transition should go off without a hitch and will not hinder insulin access, there are several overarching regulatory and educational considerations the industry should be aware of as March creeps closer.

Biosimilar Industry Experts Highlight 2019 Triumphs, Tribulations
 
By Anna Rose Welch, editor, Biosimilar Development

As we close out another year of global biosimilar successes and twists and turns, it’s always important to take stock of just how far we have come and where we still hope to go as an industry. As in years past, I reached out to members of Biosimilar Development’s editorial board and several other experts to get their take on the past year's progress.

Industry Insights
Start With The End In Mind: GMP Tech Transfer
Article | By Jenny Dunker, GE Healthcare Life Sciences

How can you be one step ahead in process development and prepare for future GMP work? Learn what tech transfer experts say about this and discover how to apply their approach to your process.

Purification Of An Acidic IgM For Large Biomolecule Purification
Application Note | By J. Greenwood II, P. Khandelwal, W. Rushton, and C. Voss, Bio-Rad Laboratories

The large size of IgMs makes their purification very challenging. See how Bio-Rad's new strong anion exchange resin (AEX), Nuvia HP-Q, has the ability to overcome the multiple issues faced when purifying large biomolecules.

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