FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Biosimilars Naming Policy Could Come by End of Year

May 6, 2015
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The FDA says it plans to provide guidance by year’s end on naming biosimilars, potentially ending much of the confusion over how the products will be labeled and tracked.

The naming guidance is one of six topics added to the agency’s 2015 guidance agenda last week — bringing to 98 the number of new and revised draft guidances CDER hopes to publish this year.

Biosimilars naming has been a hot button issue among brand and biosimilars makers. GPhA and some generics makers have argued that biosmilars need no name qualifiers and should be treated as same-name generic therapies because, in the U.S. at least, approval is based on showing that they have no clinically meaningful differences from the reference product.

In March, the FDA approved Sandoz’s Zarxio biosimilar of Amgen’s blockbuster chemotherapy product Neupogen (filgrastim) using the placeholder name filgrastim-sndz. It’s still not clear whether manufacturers will be able to propose unique names or if the agency will ask them to conform to the international nonproprietary naming system.

Other items added to the 2015 guidance agenda are:

  • Qualification of VVSymQ instrument for the measurement of varicose vein symptom burden in patients with superficial venous incompetence;
  • Evaluation of testicular toxicity during drug development;
  • Assessment of male-mediated developmental risk and mitigation for drugs;
  • The certification process for designated medical gases; and
  • Formal dispute resolution appeals above the division level.

In January, CDER updated the list to include guidance on quality metrics, social media promotion and biosimilar development, and in March added generic opioid abuse-deterrence.

The guidance agenda does not offer a timeline on when the documents will be published. View it at www.fdanews.com/4-15-FDA-Agenda.pdf. — Jonathon Shacat