Biocon has acknowledged that the FDA has held off approving its application with Mylan to market a biosimilar version of Amgen’s Neulasta® (pegfilgrastim) pending submission of additional data.
Biocon said the companies have received a Complete Response Letter (CRL) asking them to update their Biologics License Application (BLA) for MYL-1401H, a near-copy of pegfilgrastim. The agency is seeking additional chemistry, manufacturing, and controls data from facility requalification activities that follow recent plant modifications.
The CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data, or immunogenicity, according to Biocon.
“We do not expect this CRL to impact the commercial launch timing of biosimilar pegfilgrastim in the U.S.,” Biocom said in a statement. “We are committed to working with the agency to resolve the issues stated in the CRL expeditiously.”
MYL-1401H is indicated for reducing the duration of neutropenia and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer. The FDA accepted the Biocon/Mylan BLA for review in February, and set a target date of October 9 for a decision under the Biosimilar User Fee Act (BsUFA).
Mylan has exclusive commercialization rights for the proposed biosimilar pegfilgrastim in the U.S., Canada, Japan, Australia, New Zealand, the European Union, and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.
MYL-1401H is one of six biologic products being codeveloped by Mylan and Biocon through their partnership. The other four are biosimilar versions of adalimumab, bevacizumab, etanercept, and filgrastim.
The BLA for MYL-1401H was the second application submitted by the companies for a biosimilar under their partnership. The first was the BLA for MYL-1401O, a proposed biosimilar of Herceptin® (trastuzumab) marketed by Genentech, a member of the Roche group. The BLA was submitted in January. Like the branded product, the biosimilar is indicated for treating certain HER2-positive breast and gastric cancers.
In August, Biocon disclosed that the FDA extended its target date for action until December 3 on the BLA for MYL-1401O “in order to review some of the clarificatory information submitted to them as a part of the application review process.”
“This three-month extension has no impact on the anticipated timetable for commercialization of this product in the U.S.,” Biocon stated at the time.