FDA Must Do More To Counter Misinformation On Biosimilars
More should be done by the FDA to counter misinformation perpetuated by originators over biosimilars, the AAM and its Biosimilars Council have urged in comments attached to a citizen petition lodged by Pfizer.
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A citizen petition filed by biosimilars industry veteran Sarfaraz Niazi has once again urged the FDA to reconsider its approach on biosimilar naming, along with suggesting changes to language used by the regulator to describe biosimilars.
Pfizer has filed a citizen petition asking the US Food and Drug Administration (FDA) to issue guidance deterring innovator companies from suggesting that biosimilars are not as safe and effective as reference biologics.
A much-anticipated biosimilars action plan (BAP) unveiled by US Food and Drug Administration (FDA) commissioner Scott Gottlieb has been warmly received by industry. Commending the release of the plan, the US Association for Accessible Medicines (AAM) called it “another key plank in the FDA’s platform to ensure robust and timely competition from generic and biosimilar medicines”.