Stakeholders weigh in on biosimilar names

In dueling letters sent to FDA, biotech pioneers and pharmacists are arguing for and against the use of unique individual non-proprietary names for biosimilars. Last week, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization said unique names are necessary to distinguish reference, or pioneer, biologics from biosimilar versions and to ensure appropriate pharmacovigilance. The American Pharmacists Association, the National Association of Chain Drug Stores and the National Community Pharmacists Association recommended in a May letter that biosimilar products have the same name as the reference biologic to avoid confusion on appropriate use, safety and efficacy.

FDA announced in March that it is considering issuing a guidance on naming biosimilars and solicited public comment on the topic at a May public meeting. The agency has not announced whether or when it will address the issue. ...