Immune Deficiency Foundation Vice President of Public Policy Larry LaMotte today released the following statement on FDA approval of bisimilars:
"IDF urges the FDA to require clinical testing for all biosimilars. We are simply not convinced that safety can be proven through clinical analytics alone. FDA should require clinical data for each indication for which the manufacturer seeks to market the biosimilar product."
"Patients need and deserve a voice in assuring access to safe and effective biosimilars. Transparency is essential to building patient confidence in this new category of drugs. Although the meeting was specific to the proposed biosimilar of Neupogen, the implications and decision of FDA extends beyond this one product. FDA should issue final guidances to ensure a more public road map on key issues prior to approving the first biosimilar in the United States. To do otherwise undermines patient confidence."
IDF's statement to the Oncologic Drugs Advisory Committee can be found here.