- The Food and Drug Administration has delayed its review of Mylan N.V. and Biocon Ltd's proposed biosimilar copy of Herceptin, setting back the two companies' hopes to secure the first U.S. approval of a knockoff version to the blockbuster breast cancer drug.
- Mylan and Biocon won the unanimous support of an FDA advisory panel in July for the drug, and a decision from the regulator had been expected by September 3. That target action date is now pushed back three months to December 3.
- In a statement, Biocon said the extension will have "no impact on the anticipated timetable for commercialization of the product in the U.S." The FDA's decision to push back its review doesn't appear related to manufacturing issues which have dogged the Indian drugmaker, but rather due to further review of clarifying information submitted as part of the application process.
Roche can rest a little easier, for the next three months at least. But the delay for Mylan and Biocon's copycat biologic doesn't change the fundamental picture for the Swiss giant.
Two other Herceptin biosimilars are awaiting approval in the U.S. following August submissions from the team of Amgen, Inc. and Allergan plc as well as from Korean drugmaker Celltrion, Inc.
While Roche plans to defend Herceptin, it will face biosimilar competition sooner rather than later.
Mylan and Biocon looked set to clear regulatory review first after sailing through the advisory committee meeting in July. That's likely still to be the case, though the other two will now be following more closely behind.
Mylan, though, has inked a settlement agreement with Roche back in March which grants the company a license to market its Herceptin biosimilar in all countries except Japan, Brazil and Mexico. In exchange, Mylan dropped two legal challenges held by Roche subsidiary Genentech on Herceptin.
In Europe, Biocon has also run into problems, withdrawing an application for approval of the copycat biologic in July after the European Medicines Agency announced it would need to re-inspect one of Biocon's drug product facilities.
The company is currently carrying out corrective and preventative actions and will subsequently seek re-inspection and resubmission. Delays from the FDA, however, seem to be connected with paperwork rather than production facilities.
"The US FDA has notified our partner Mylan that they will extend the target action date for their trastuzumab 351(k) application to Dec 3, 2017 in order to review some of the clarificatory information submitted to them as a part of the application review process," said a Biocon spokesperson.