FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for February 2015

Posted on Friday, February 13 2015 at 9:03 pm by -

9th Cir. Backs FTC Hospital Merger Challenge

On February 10, 2015, the Ninth Circuit affirmed a district court ruling that the acquisition of an Idaho physician group practice by St. Luke’s Health System was anticompetitive. Closely watched by health care providers and other stakeholders, the St. Luke’s case is thought to be a key indicator of how courts will balance Affordable Care Act (ACA) requirements for integrated healthcare services with concerns about increasing healthcare provider concentration.
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Posted on Wednesday, February 4 2015 at 8:56 pm by -

First Biosimilar Recommended for Approval by FDA

On January 7, industry stakeholders lauded as historic a U.S. Food and Drug Administration (FDA) advisory committee’s recommendation to approve the first biosimilar application in the U.S. The FDA defines a biosimilar as a biological product that is highly similar to a US-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.1 Sandoz, a Novartis company, had submitted the application to the FDA for approval of its biosimilar to Amgen’s Neupogen® (filgrastim).2
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