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February 17, 2017

Recent Stories

From Drug Benefit News - CMS is planning changes to the way it tracks opioid overuse and calculates the post-discharge medication reconciliation measure beginning in 2018, the agency said in its annual Advance Notice and draft Call Letter posted Feb. 1. The proposed changes are among numerous tweaks to stand-alone Part D Prescription Drug Plans (PDPs) and Medicare Advantage prescription drug (MA-PD) plans outlined in the 159-page document. CMS also proposed small adjustments in Part D benefit parameters and in some star rating measures. Comments on the changes are due to CMS on March 3. Read more

As specialty drug costs continue to rise and show few signs of… Read more

Pharmacy benefit managers Express Scripts Holding Co. and CVS Health could be… Read more

The manufacturer of an insulin autoinjector is once again in the crosshairs… Read more

From the Editor

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January 17, 2017
Long-Awaited Biosimilar Interchangeability Draft Guidance Is Out

FDA finally unveils interchangeability draft guidance for biosimilars, expects “that applications generally will include data from a switching study or studies in one or more appropriate conditions of use,” among other criteria www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid...

January 12, 2017
FDA Finalizes Naming Guidance for Biologics, Biosimilars

In final guidance, FDA says all biologics, not only biosimilars, will have four-letter suffixes; agency still considering “appropriate suffix format” for interchangeable biosimilars http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...

December 28, 2016
FDA Issues More Biosimilar Guidance

FDA issues guidance on clinical pharmacology data needed to show a product is biosimilar to its reference drug http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...

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