Biosimilars Forum Statement on Citizen Petition to the Food and Drug Administration
Having submitted comments to the Citizen Petition to the Food and Drug Administration with regard to clarifying appropriate sponsor communications on biosimilar products, the Biosimilars Forum released the following statement:
“The Biosimilars Forum is firmly committed to improving awareness about the effectiveness of biosimilars and combating misinformation about their safety. In order to ensure that patients are able to benefit from these life-saving treatments, any efforts to undermine confidence in biosimilars must be taken seriously and responded to appropriately.
“We believe supplemental guidance from the Food and Drug Administration is needed to ensure reference product sponsors and other organizations understand how to communicate about biosimilars in a manner reflected under current law. The FDA should also send communications to organizations that conduct biosimilar misinformation campaigns requesting the immediate suspension and withdrawal of such campaigns.
“The Biosimilars Forum also hopes that the FDA will take appropriate action in its educational resources — such as inclusion of a ‘Facts about Biosimilars’ page — to make sure that our national dialogue about biosimilars is driven by evidence-based fact, rather than misleading characterizations.”
To view the full comments, click here.