Newsletter | January 30, 2020

01.30.20 -- Fresenius Kabi's Quest For Efficient Biosimilar R&D

Featured Editorial
ISO 10993-1: Considerations For Drug Delivery Devices
By Michael Song, Ph.D.

ISO 10993-1 is typically the starting point for biocompatibility study planning as it provides a general overview and recommendation on testing endpoints. While this may seem straightforward, there are a number of intricacies when conducting biocompatibility studies.

Biosimilar Litigation Review: BPCIA Cases Settled Or Dismissed In 2019
By P. Chen, F. Eyzaguirre, T. Francis, and J. Shmuel, Fish & Richardson

This is the second article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding BPCIA district court litigation and reviewed ongoing district court cases. In Part 2, we turn our attention to BPCIA district court cases that were settled in 2019.

Fresenius Kabi: The Quest For More Efficient Biosimilar R&D
By Anna Rose Welch, editor, Biosimilar Development

Following the news of Fresenius Kabi’s new biosimilar R&D lab, I reached out to one executive to discuss the current challenges in biosimilar R&D, including maintaining the delicate balance between biosimilar R&D and commercial teams as Fresenius Kabi prepares for a long future in the biosimilar space.

Industry Insights
Master Analytical SEC Running Conditions
Q&A | By Jon Lundqvist, GE Healthcare Life Sciences

Need to find out how to calibrate your size exclusion chromatography (SEC) column, or how different additives affect your results? Read these useful insights.


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!

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