Capitol Hill Panel Explores Need for Transparency with Biosimilar Medicines
Though newly finalized guidance from the FDA has provided some clarity on biosimilarity, crucial questions about the regulation of biosimilars remain unanswered.
AfPA Video Explains “How to Safely, Effectively Substitute Biological Medicines”
When it comes to sophisticated and powerful medications like biologics, the details matter.
IfPA Policy Brief Calls for Transparent Biosimilar Labeling
In the Institute for Patient Access’ new policy brief, “Informed Prescribing,” authors David Charles, MD, and Mary Ann Chapman, PhD, explain why biosimilar medications should come with transparent, accurate prescribing information.
U.S. Senators Question FDA’s “Placeholder” Biosimilar Naming Solution
The Food and Drug Administration’s distinct name for the first biosimilar was a “placeholder,” the agency declared on March 6.
Don’t Keep Physicians Guessing About Biosimilar Swaps
State legislatures across the country are considering bills to ensure that physicians know when a pharmacist swaps a prescribed biologic medicine for a new “biosimilar.”
Biosimilar Labeling Stirs Concerns
Will the labels used for biosimilars help – or hinder – the adoption of these new medications?
First Biosimilar Approval Leaves Patient Safety Questions Unanswered
On Friday the Food and Drug Administration approved the United States’ first biosimilar medicine.
Europe and Australia Reshuffle on Generics, Biosimilars
Europe and Australia are reassessing, recalling and reflecting on biosimilars and generic medications.
As Biosimilar FDA Approval Nears, What Can Be Learned from India?
Last week, the United States inched closer to its first biosimilar approval. At a Wednesday meeting of the Food and Drug Administration’s Oncological Drugs Advisory Committee, panelists recommended approval for a filgrastim biosimilar.
New AfPA Video Urges Distinct Names, Comprehensive Testing for Biosimilars
The Alliance for Patient Access released today a new policy video offering a vital prescription for safe use of biosimilars: distinct naming conventions and comprehensive testing.
