FDA Will Unveil Four Draft Guidances on Biosimilars This Year

The FDA is on track to release draft guidance on naming biosimilars this year, an FDA official said last week.

The guidance has been long in coming, in part because the agency wants to avoid adopting a naming system that will confuse people or put biosimilars at a disadvantage, and it wants a system that allows for safe use and pharmacovigilance, Sally Howard, deputy commissioner for policy, planning and legislation, said during a meeting sponsored by the Alliance for Health Reform in Washington, D.C.

Three other biosimilars draft guidances — covering labeling, statistical approaches to evaluation of analytical similarity data, and considerations in demonstrating interchangeability to a reference product — also are expected this year, Howard said.

Biosimilars naming has been a hot button issue among brand and biosimilars makers, with GPhA and some generics makers arguing that biosimilars don’t need name qualifiers and should be treated as same-name generic therapies.

In March, the FDA approved Sandoz’s Zarxio biosimilar of Amgen’s blockbuster chemotherapy product Neupogen (filgrastim) using the placeholder name filgrastim-sndz. It is not yet known if manufacturers will be able to come up with unique names or if the agency will ask them to conform to the INN system.

Patient safety and accessibility will be ensured if biosimilars share the same international nonproprietary name, or INN, with the original biologic, said Sumant Ramachandra, chief science officer at Hospira, during a panel discussion with Howard and other biosimilars makers. Adding more complexity to the current naming system would increase confusion for physicians, pharmacists and patients.

Ramachandra pointed out that biosimilar products have been on the European market since 2006 without unique INNs, and pharmacovigilance has been maintained.

Ramachandra also urged the FDA to consider extending approval of disease indications for biologics to biosimilars without additional clinical trials on a case-by-case basis, if biosimilarity has been demonstrated in comparative studies. — Jonathon Shacat