Trastuzumab commercialisation on track, Biocon says after USFDA extends review deadline by 3 months

Is this an outcome of US FDA observations during cGMP audit?

As mentioned, this extension of the target action date is linked to the review of the clarificatory information sought as part of the application review process. This information is not related to any cGMP audit observations at our manufacturing facilities.

Are you confident of getting the approval on Dec 3, 2017?

In July, our product became the first biosimilar Trastuzumab to be recommended for approval by the US FDA Oncologic Drugs Advisory Committee. The unanimous endorsement by the committee validated the quality of our biosimilar product in terms of safety, purity and potency in comparison to the reference product. Given these developments, we remain confident of getting approval for our biosimilar Trastuzumab which will expand access to a high quality, affordable option for treating HER2-positive breast cancers in the US. It will not be appropriate for us to make any predictions on definitive approval timelines.

Is this the first time that target action date has been extended?

As per publicly available data, such extensions are not unusual and have occurred as part of the review cycle in a couple of other prior biosimilar approvals by the USFDA.

Will this delay the launch in the US?

This three-month extension has no impact on the anticipated timetable for commercialization of this product in the US.

When was Mylan/ Biocon informed about the extension of target action date?

We were informed about this extension recently.