Data from Australia, Japan, and Europe indicates that varying nonproprietary names
reduces biosimilars' market presence, thus restricting competition in the market for biologies.
Different nonproprietary names
for a biologic and the biosimilar medicine patterned on that biologic could create confusion among the clinicians who rely on international and local standards to fill prescriptions for patients, potentially resulting in safety and medication access issues
The responses of the European physicians demonstrate the need for distinguishable nonproprietary names
to be given for all biologics.
Food and Drug Administration (FDA) asking the agency to require biosimilars to bear nonproprietary names
that are similar to, but not the same as, those of their reference products or of other biosimilars.
This report explains new standards and guidelines the committee recently adopted and recommended for use, specifically the International Chemical Reference Substances and International Infrared Reference Spectra, specifications (in principle) for male latex condoms and Tcu380A intrauterine devices for purchase by United Nations agencies, active pharmaceutical ingredient master file procedures and international nonproprietary names
for biological and biotechnological substances.
The entries, which are organized alphabetically, each contain a list of nonproprietary names
and synonyms; detailed chemical information, including the structural formula; a description; applications; method of manufacture; handling precautions; regulatory status; and related substances, among other information.
We strongly believe the final regulatory structure for biosimilars must include mechanisms to allow for robust post-marketing data collection and evaluation along with unique trade and nonproprietary names
, so that safety issues can be recognized quickly and patient risk can be limited.
The Company also announced today that the United States Adopted Names Council (USAN) and World Health Organization (WHO) International Nonproprietary Names
(INN) Expert Committee have approved palifosfamide as the non-proprietary name for isofosforamide mustard (IPM), the active pharmaceutical ingredient in ZIO-201.
Separately the Company announced that the United States Adopted Names Council (USAN) and World Health Organization (WHO) International Nonproprietary Names
(INN) Expert Committee have approved darinaparsin as the non-proprietary name for ZIO-101 (for all forms of the drug).