FDA Accepts Applications for Rituximab and Filgrastim Biosimilar Candidates

According to press releases this week, the FDA has recently accepted two new Abbreviated Biologics License Applications (aBLA) for review.

First, Adello Biologics yesterday announced that the FDA has accepted its aBLA for its proposed biosimilar of Neupogen® (filgrastim), which is indicated for, among other things, the treatment of neutropenia-related conditions in cancer patients receiving myelosuppressive chemotherapy.  According to the press release, Adello’s “submission is supported by similarity data from analytical, pre-clinical and clinical development studies, comparing the biosimilar candidate to Neupogen®.”  The FDA has previously approved one other filgrastim biosimilar through the BPCIA pathway: Sandoz’s Zarxio®, which was the first biosimilar product to obtain FDA approval and to launch in the United States.

Second, Sandoz today announced that the FDA has accepted for review its aBLA for a proposed biosimilar of Rituxan® (rituximab), which is indicated for the treatment of certain blood cancers and immunological diseases.  Sandoz stated that its application contains “a comprehensive data package that includes analytical, preclinical and clinical data,” such as a pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis, and a Phase III confirmatory safety and efficacy study in follicular lymphoma.  Sandoz’s announcement today is in line with its indication earlier this summer that it was on track to file an aBLA for its proposed rituximab biosimilar (GP2013) in the second half of this year.  Sandoz’s press release notes that its rituximab biosimilar was already approved by the European Commission in June 2017 for use in Europe, where it is marketed as Rixathon®.  The FDA, however, has yet to approve any rituximab biosimilar product for use in the United States.

Stay tuned to Big Molecule Watch for further updates.