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.
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.
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.
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.