The FDA issued a complete response letter to Tanvex BioPharma for its proposed biosimilar for Amgen’s Neupogen (filgrastim) for the creation of white blood cells following chemotherapy.
The Taiwanese company said the agency did not raise any alarms in the CRL about safety or ask for more clinical data, but it did not give details on the information the FDA wants to see before approving the BLA.
The company has faced other hurdles over the biosimilar this year, including a lawsuit in July from Amgen. The suit alleges the company infringed on an Amgen patent involving methods for refolding proteins. Tanvex responded with “defenses and counterclaims of non-infringement and validity,” the company said.