05/21/2019

Recent Oncology Related Drug News

FDA Finalizes Rules for When a Biosimilar is ‘Interchangeable’ with a Biologic

WASHINGTON — The FDA on Friday spelled out exactly what kind of studies biosimilar drug makers must conduct in order to be considered “interchangeable” with a biologic drug the way a generic functions for a normal medicine. It’s the agency’s final word on a controversial and long-running fight over how it will define those rules.  READ MORE 

FDA finalizes guidance on what counts as an interchangeable biosimilar

TheThe FDA has finalized its long-awaited guidance on when biosimilars can be considered interchangeable with biologics.

Six things to know:
1. When a biosimilar gets an "interchangeable" designation, the therapy may be substituted for the biologic without the involvement of a prescriber, similar to how generics are substituted for brand-name drugs. Biologics can cost hundreds of thousands of dollars and biosimilars are expected to help lower these costs.

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HHS Finalizes Rule Requiring Manufacturers Disclose Drug Prices in TV Ads to Increase Drug Pricing Transparency

On Wednesday, May 8th, Health and Human Services Secretary Alex Azar announced a final rule from the Centers for Medicare & Medicaid Services (CMS) that will require direct-to-consumer television advertisements for prescription pharmaceuticals covered by Medicare or Medicaid to include the list price – the Wholesale Acquisition Cost – if that price is equal to or greater than $35 for a month’s supply or the usual course of therapy.  READ MORE and ACCESS THE FINAL RULE AND FACT SHEET