Newsletter | December 12, 2019

12.12.19 -- Biosimilars: Not Just Big Pharma's Playground

 
Featured Editorial
Biosimilars: Not Just Big Pharma’s Playground
 
By Anna Rose Welch, editor, Biosimilar Development

In addition to discussing past challenges, two experts from NeuClone shared insights into the critical analytical, manufacturing, and clinical considerations that are important for any company — but especially for smaller companies — when developing biosimilars.

Real-World Evidence & Biosimilars: Weighing The Potential Impact
 
By Anna Rose Welch, editor, Biosimilar Development

Here, IQVIA’s Jaclyn Bosco, Sandoz’s Edward Li, and the University of Messina’s Dr. Gianluca Trifirò discuss how real-world evidence (RWE) can impact regulator and payer decisions, shape treatment pathways, and encourage greater stakeholder comfort and action toward biosimilars.

EU5 Biosimilar Adoption: What Can The Past Tell Us About The Future?
 
By Jose Ignacio Diaz, general manager, Emergpharma

In this article, we review the penetration of biosimilars in the top five EU markets, with special emphasis on the years 2016 and 2018, as well as the key elements that could explain these results.

Industry Insights
A Model System For Fast Screening Of Optimal Protein Purification Conditions
Application Note | Bio-Rad Laboratories, Inc.

Identifying optimal purification conditions can require a time-consuming evaluation of many parameters. This study highlights a model system for screening optimal protein purification conditions on a mixed-mode cation exchange resin using a statistical software generated design of experiment model.

Smarter Development Of Chromatography Processes: Reducing Timelines And Improving Outcomes
Webinar | GE Healthcare Life Sciences

Time-to-experiment, time-to-clinic, and time-to-market are becoming even more important for developers and manufacturers of biopharmaceuticals. At the same time, the amount of data enclosed in biologic license applications is more comprehensive to avoid extended review. In this webinar we will review three fields that enable reduced timelines and improved outcomes of process development activities.

Sponsor
 

We are delighted to announce that our annual Biosimilar Medicines Conference will be taking place March 26 and 27, 2020, in Amsterdam, the Netherlands. During these two interactive days leaders and world experts in biosimilar medicines will gather and debate the evolving biosimilar medicines landscape and new trends.

The various sessions will cover all relevant areas of healthcare policy, market access, scientific developments, regulatory, and clinical experience. Join us and have your say!

Solutions
NGC Chromatography Systems For Protein Purification
Bio-Rad Laboratories, Inc.
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