US FDA to take more time to review Biocon-Mylan’s trastuzumab application

Biocon Ltd on Wednesday said the US Food and Drug Administration (FDA) will take three months more to review the application for a biosimilar version of Roche Holding AG’s breast cancer drug Herceptin filed by partner Mylan NV.

In a stock exchange filing, the Bengaluru-based drug maker said the FDA has notified partner Mylan that it will extend the target action date for the trastuzumab application to 3 December in order to review some information submitted to it 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 US,” Biocon said.
Target action dates are the FDA’s internal deadlines for action on all applications. The regulator had accepted Biocon-Mylan’s trastuzumab biosimilar application for review in January 2017.
“FDA extending goal dates for biosimilars is not unusual and has happened in the past. We have recently submitted additional information on our trastuzumab application, which is extensive and hence FDA needs some time to review it. We can’t get into specific details,” said Narendra Chirmule, senior vice-president and head of research and development (R&D) at Biocon.
“While US FDA’s clearance of our manufacturing plant is necessary to get final approval for trastuzumab, this extension of target action date is more to do with clarificatory information on the dossier, which is not related to plant audit,” Chirmule added.
The US drug regulator had inspected Biocon’s Bengaluru unit between 27 March and 7 April this year and made eight observations relating to deviations from good manufacturing practices. The trastuzumab biosimilar will be manufactured at the same unit.
The company has been implementing remedial measures at the Bengaluru unit to address the FDA’s concerns.
“Biocon will not get approval for its biosimilars until its plant issues are resolved. Harmonisation and exchange of data between global regulators is increasing and hence the company needs to clear observations of both US FDA and EMA (European Medicines Agency). Some of the observations made by French regulator are pretty serious,” Surajit Pal, analyst at Prabhudas Lilladher, said on this development.
The French regulator had made 35 observations on the company’s drug product unit in Bengaluru after an inspection in March, out of which 11 were major deficiencies.
The extension of target action date by FDA increases uncertainties relating to application and launch of the biosimilar in the US and is therefore negative for investors, said a Mumbai-based analyst, requesting anonymity.
This announcement came after trading hours.
Shares of Biocon closed up 0.8% at Rs344.10 on the BSE while the benchmark Sensex Index ended 0.8% higher at 31,646.46 points.
In July, the FDA’s oncology drugs advisory committee had recommended approval of Biocon-Mylan’s biosimilar trastuzumab, as data showed no clinically meaningful differences between the biosimilar and Roche’s innovation drug Herceptin in terms of safety, purity and potency.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by the companies.
Mylan has exclusive commercialization rights for biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand and in 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.


Popular posts from this blog

EMA Recommends Extension of Indications for Ramucirumab

Dr. Hootie Warren takes helm of Fred Hutch Global Oncology

Bristol-Myers Squibb and Clovis Oncology Announce a Broad Clinical Collaboration to Evaluate Combination of Opdivo (Nivolumab) and Rubraca® (Rucaparib) in Phase 2 and Pivotal Phase 3 Clinical Trials in Multiple Tumor Types