miércoles, 5 de febrero de 2020

The feds are cracking down on biosimilar-blocking

The Readout
Damian Garde & Meghana Keshavan

The feds are cracking down on biosimilar-blocking

Depending on whom you ask, it may be too soon to say whether biosimilars will make a big dent in U.S. health care spending. But it’s far easier to say that any moves by the biopharma industry to impede wider use of biosimilars won’t help matters.

With that in mind, the Food and Drug Administration and the Federal Trade Commission said this week that they would take a number of steps to ensure that companies seeking to sell biosimilars have a chance to compete for U.S. patients.

Among them, according to STAT’s Ed Silverman, is addressing any false or misleading statements that misrepresent the safety or effectiveness of biosimilars and examining patent settlements that may delay biosimilar product launches.

Read more.

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