Newsletter | October 3, 2019

10.03.19 -- How This Initiative Improved Biosimilar Infliximab Uptake

Featured Editorial
How One Rheumatology Practice Bolstered Uptake Of Biosimilar Infliximab
By Anna Rose Welch, editor, Biosimilar Development

In this article, Dr. Edgerton walks me through AHG’s considerations and efforts in gaining payer buy-in on this value-based pathway, as well as how this initiative has given rise to a new, rheumatology-centric group purchasing organization.

FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018
By Jerry Chapman

In this two-part article, two experts present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. This part unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.

Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”
By C. Landmon and C. Gallo, Ph.D., Axinn, Veltrop & Harkrider LLP

There is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. Industry players should monitor this bill and other efforts to address the insulin dead zone, given how critical this product is to so many people.

Industry Insights
Understanding And Controlling Raw Material Variation In Cell Culture Media
White Paper | GE Healthcare Life Sciences

An organized effort across the biopharmaceutical industry, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

Improved Process Economics Of Humira Biosimilar Purification
Application Note | By R. Drevland, et. al., Bio-Rad Laboratories, Inc.

This application note proposes an alternate but equally effective approach to biosimilar purification by substituting a less-expensive ion exchange resin for the affinity capture step.

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