U.S. Drug Regulator Seeks More Data From Biocon On Cancer Treatment Biosimilar
The announcement means that the target action date for Pegfilgrastim will be missed.
Biocon Ltd. said the U.S. drug regulator’s decision to not approve the biosimilar pegfilgrastim, being jointly developed by Mylan, in the present form will not delay the commercial launch of the drug given during chemotherapy to cancer patients.
The U.S. Food and Drug Administration issued a complete response letter for Mylan's Biologics License Application of the biosimilar amid pending update of manufacturing data after modifications at its Bengaluru facility, Biocon said in an exchange filing. The U.S. FDA had highlighted quality lapses at the facility.
The regulator hasn’t requested a re-inspection of the Bengaluru plant and the company assumes the facility will be cleared after completing corrective actions that were initiated due to inspections in April and June, Bloomberg quoted Chief Executive Officer Arun Chandavarkar as saying.
Morgan Stanley said none of the pegfiltrastim filers received approval in the first review cycle. Delay in approvals and launch timelines of the early filers—Apotex, Sandoz, Coherus —to the end of 2018 should help Biocon to be close to the first wave of launches.
Shares of Biocon Ltd. rose as much 5 percent, the most in over a month, after the filing.
However, brokerage Haitong Securities India Pvt. Ltd. said it’s a “potential negative” for the drugmaker’s approval timelines, brokerage Haitong Securities India Pvt. Ltd. said. “Biocon would have to put a big laundry list of completions in place before the U.S. FDA would look at the biosimilar,” Rakesh Nayudu, healthcare analyst at the brokerage, said.
Nayudu said Biocon will have to follow two processes. First would be to get an approval for the Bengaluru facility and then generate chemistry and manufacturing control data afresh and match it with the previous data from the facility and R&D unit.
(Updates an earlier version to add Biocon statement)