Regulatory Focus™ > News Articles > 4 > USP Will Not Move Forward With Proposal on Biologics Naming

USP Will Not Move Forward With Proposal on Biologics Naming

Posted 30 April 2018 | By Zachary Brennan 

USP Will Not Move Forward With Proposal on Biologics Naming

USP announced Friday that it will not move forward with a proposal published in the Pharmacopeial Forum on biologics naming, and that it is postponing the implementation date (scheduled for 1 May) of the monograph for epoetin, a biologic commonly used to treat anemia.

The shift by USP follows pushback from the US Food and Drug Administration (FDA) and questions raised by Amgen.

“Acknowledging the critical role public standards play in ensuring the quality of all drugs, including biologics, and facilitating access to them, USP will continue its focus on developing ‘performance standards, which are applicable to classes of biologics (e.g. monoclonal antibodies or cell therapies), as well as standards for raw materials,” USP said.

USP also said it intends to use the descriptive term “with sensor” in approved product names – for drug therapies with sensor technology that verifies when a patient has taken a medication. USP said it did not receive comments on this amendment, but FDA previously expressed its support for it.

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe