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FDA Finds Itself in Catch-22 Situation After Naming Guidance
Draft guidance issued by the FDA in August called for a four-letter suffix to be added to all nonproprietary biologic product names, but when future guidance is developed, the four-letter rule may not be needed.
According to Michael Mikhail, a regulatory consultant specializing in biosimilars, “the FDA has put itself in a catch-22 situation” when it comes to future guidance on the interchangeability of biosimilars and biological products. During a panel discussion at the Convention on Pharmaceutical Ingredients (CPhI) Worldwide Pre-Connect Conference, Mikhail stated that “the proposal to have an INN [International Nonproprietary Name] with an added four-letter rule has left the FDA trapped.”
“When interchangeability guidelines come along, there shouldn’t be any need for this four-letter distinguisher,” Mikhail said.
Under the rule, for example, Amgen’s reference product Neupogen will be known as filgrastim-jcwp, whereas the copycat drug Zarxio (Sandoz)––which became the first biosimilar launched in the U.S. last month––will be named filgrastim-sndz.
In the U.S., a biosimilar needs to be cleared by the FDA for “biosimilarity” and then, if requested by the biosimilar manufacturer, it must be approved as being “interchangeable” with its reference product. Laws on interchangeability and substitution with biologics vary from state to state.
The FDA is already facing criticism from the Senate on the current lack of interchangeability guidance, and the agency’s INN guidelines could lead to further controversy.
Source: BioPharma Reporter, October 13, 2015