Biologics Prescribers to FDA: Biosimilars Need Distinct Names
A group of specialty physician societies and members of AfPA’s National Physicians Biologics Working Group made a collective appeal to the Food and Drug Administration today for giving biosimilar follow-ons distinct names.
Biosimilar Naming, Extrapolation Pose Tough Questions for FDA
The FDA’s first biosimilar approval application has stirred high hopes among some members of the health care community – and heated debate among others.
In the Name of Patient Safety: Why Biosimilars Need Distinct Identifiers
An opponent to distinct names for biosimilar medications has petitioned the Food and Drug Administration with a new argument: Same old, same old works just fine.
Panel Makes Case for Unique Drug Names
Tracking and analyzing patients’ adverse reactions to medications – a process known as pharmacovigilance – is crucial to patient safety.
WHO Calls for Improved, Science-based Regulations on Biosimilars
Patients worldwide need access to affordable biosimilars, the World Health Organizations’ World Health Assembly (WHA) says, but not at the expense of safety or science.
Final Part D Rule Protects Access – For Now
Medicare beneficiaries and patient advocates breathed a collective sigh of relief last month when the Centers for Medicare and Medicaid Services (CMS) issued its final Part D rule – which targeted program abuse instead of implementing cost-cutting restrictions on medication access.
Drug-Naming Debate Sparks Patient Safety Concern
What’s in a name? A lot, as the Food and Drug Administration and World Health Organization are discovering.
Less Clinical Data May Mean Fewer Prescriptions for Biosimilars
The Food and Drug Administration may require less clinical data to approve biosimilars (imitations of powerful biological medications).
Biosimilars Need Distinguishable Names
Biologics are the fastest growing segment of new medical breakthroughs.
VIEWPOINT: Why Neurologists and Their Patients Must Be Informed When Pharmacists Switch Biologics
Over the past several years, in response to campaigns by the AAN and state neurology societies, a growing number of states have passed laws prohibiting pharmacists from substituting one generic version of an antiepileptic drug (AED) for another without notifying the physician.
