Biosimilars: US FDA Education Campaign Is Non-Committal On Non-Medical Switching
Substituting a biosimilar for a reference product is a state issue and outside agency's purview, FDA says.
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US FDA hands Pfizer its second complete response letter for its proposed biosimilar to Epogen/Procrit, citing manufacturing compliance concerns at a legacy Hospira manufacturing facility in Kansas that was the target of a February warning letter. Issue “is not directly related to EPO itself,” Pfizer’s Salomon Azoulay says.
Analysts expect potential broad uptake of biosimilars in chronic kidney disease treated at dialysis centers, which could lead to patients being switched off Amgen's Epogen.
New FDA Commissioner tells employees that 'too many consumers are priced out of medicines they need' and that FDA must take meaningful steps to get lower cost alternatives to market.