The US FDA has issued a complete response letter for insulin glargine. Kiran Mazumdar Shaw, CMD of Biocon, spoke to CNBC-TV18 about the response letter.
“The positive aspect of the complete response letter is that the agency has essentially focused on the resolution of the observations made at the pre-approval inspection in early July,” said Mazumdar Shaw.
“We have provided the corrective action preventive action (CAPA) and we had also provided an interim report on the CAPAs that has been resolved. We are confident that we will resolve the rest of the CAPAs in the next few months and thereafter we will seek approval,” she added.
About the Malaysian facility, the CMD said, “The facilities were inspected in July and we have been asked to look at some aspects of making the system a little more vigorous. Therefore, we are doing that and we are confident of implementing the CAPA that we have presented to the agency.”
“Therefore, given the fact that there are no concerns around the scientific and the clinical and the quality of the product, this is good news for us. So it’s a matter of time and we are confident that we will be in time for the market launch after 30-month hold which gets over in March,” the CMD added.
Talking about the insulin glargine launch, she said, “The potential launch time was after March 2020, which is the end of 30-month hold. There was a 30-month hold that was put on us because it’s under 505(b)(2) pathway when Sanofi started litigation us on some IP issues and based on the regulatory requirement there is a 30-month hold to resolve this. So we believe we should be on time for that.”