Update: US FDA Warns of 'Swift Action' Against Copycat Drugs

MT Newswires Live02-06 22:54

(Updates to include a statement from a Novo Nordisk spokesperson, the status of a comment request to Hims & Hers Health, and Hims & Hers Health's recent stock move in the last three paragraphs.)

The US Food and Drug Administration will "take swift action against companies mass-marketing illegal copycat drugs" of FDA-approved products, FDA Commissioner Marty Makary said in a late Thursday post on social media platform X.

"The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs," Makary said. No company was mentioned in the post.

Reuters reported Friday that the announcement followed Hims & Hers Health's (HIMS) launch of a cheaper alternative to Novo Nordisk's (NVO) FDA-approved Wegovy pill.

A Novo Nordisk spokesperson told MT Newswires that Hims & Hers Health's knockoff semaglutide pill "uses an untested delivery mechanism that lacks supporting evidence and has never been reviewed by FDA" and the safety and effectiveness concerns led the regulator to add liposome drugs to products that may not be compounded.

Hims & Hers Health did not immediately respond to MT Newswires' request a for comment.

Shares of Hims & Hers Health were down more than 6% in recent trading Friday.

Price: 46.48, Change: +3.13, Percent Change: +7.22

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