FDANews
FDAnews Drug Daily Bulletin

FDA Plans to Receive Five Biosimilar Applications Per Year

July 8, 2015

The FDA says it expects to receive five 351(k) applications from companies seeking to file biosimilar product applications in fiscal 2015.

In a notice posted to the Federal Register, the FDA says it expects each company to devote 860 hours per response. In addition, it expects two companies to file applications for proposed interchangeable products supplements and devote another 860 hours per response.

The FDA says it is still on track to issue draft guidance on demonstrating biosimilar interchangeability to a reference product later this year.

Three other biosimilars draft guidances — covering naming, labeling and statistical approaches to the evaluation of analytical similarity data — also are expected this year.

Read the notice at www.fdanews.com/6-15-FDA-351kNotice.pdf. — Jonathon Shacat