Stakeholder letter to FDA on "Proposed Suffix for the Proper Name of a Biological Product."
May 7, 2019
Stakeholders urge FDA to change course on new guidelines to require suffix on biosimilar drugs.
According to the letter, "as stakeholders that support patient access to affordable medicines and competition in the pharmaceutical marketplace, we applaud the Food and Drug Administration’s (FDA) efforts to foster the development of biosimilar medicines for America’s patients. However, we are concerned that as recently updated, the FDA policy for the naming of biological products could harm the development of a robust biosimilars market in the United States, putting access and savings for patients in jeopardy."