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# Alymsys Patient Brochure False or Misleading: FDA
- URL: https://www.fdaweb.com/alymsys-patient-brochure-false-or-misleading-fda/
- Published: 2026-04-09T12:00:00.000Z
- Updated: 2026-09-14T13:37:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160957

The CDER Office of Prescription Drug Promotion (OPDP) says a patient brochure for Amneal Pharmaceuticals’ Alymsys (bevacizumab-maly), a biosimilar of Genentech’s Avastin, is false or misleading for multiple reasons. A 3/31 [Untitled Letter](http://www.fda.gov/media/191883/download?attachment&ref=fdaweb.com) cites concerns that the brochure:

- fails to provide material information about the full FDA-approved indication from the Indications and Usage section of the prescribing information;
- fails to disclose material risk information about serious risks associated with Alymsys;
- includes a statement referring to the full prescribing information that does not mitigate the misleading omission of risks;
- minimizes the risk information that it includes; and
- does not present risk information in the order of severity and fails to disclose much of the information about Warnings, Precautions, and Adverse Reactions.

“The totality of the omission of material information regarding approved indications and the serious risks of Alymsys, in addition to the minimization of risk information that is presented, is concerning from a public health perspective because they serve to misleadingly represent Alymsys as safer and more effective than has been demonstrated, as well as safer and more effective that the bevacizumab reference-listed drug (Avastin) when this has not been demonstrated,” OPDP says. It says that since FDA approved Alymsys as a biosimilar with the expectation that there are no clinically meaningful differences between the two drugs, representations or suggestions that Alymsys is safer or more effective than Avastin are misleading.

Amneal was told to respond with a list of all its Alymsys communications that contain representations like those in the patient brochure and a plan to either discontinue such communications or stop distributing the drug.