August 4, 2015
How can regulators effectively create distinguishable names for biosimilars?
June 18, 2015
On behalf of the Global Alliance for Patient Access I participated in this week’s International Nonproprietary Names (INN) Biological Qualifier (BQ) Comments Review: Front Page Meeting with Stakeholders, held at the World Health Organization Headquarters in Geneva, Switzerland.
May 23, 2015
By David Charles, MD and Mary Ann Chapman, PhD Every prescription medication approved in the United States is accompanied by…
May 21, 2015
Though newly finalized guidance from the FDA has provided some clarity on biosimilarity, crucial questions about the regulation of biosimilars remain unanswered.
May 18, 2015
When it comes to sophisticated and powerful medications like biologics, the details matter.
May 4, 2015
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.
May 1, 2015
The Food and Drug Administration’s distinct name for the first biosimilar was a “placeholder,” the agency declared on March 6.
March 31, 2015
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.”
March 24, 2015
Will the labels used for biosimilars help – or hinder – the adoption of these new medications?
March 9, 2015
On Friday the Food and Drug Administration approved the United States’ first biosimilar medicine.
