Biocon opened 3% lower today morning at Rs.227.90 and went down further to an intraday low at Rs.226.40. It has recovered a bit but remains very much in the red.
On Saturday, the US FDA issued a complete response letter for the new drug application for Insulin Glargine, filed by Biocon’s partner Mylan N.V. The drug is used to treat type 1 and type 2 diabetes.
A complete response comes from the FDA when it has ascertained that it will not give its approval for the application or abbreviated application in the preset form. The FDA did not identify any outstanding scientific issues with the application.
The impact of this is that the much awaited commercial launch of Glargine will get further delayed though the company maintains that it will not. Biocon has plans to launch the product in the US in March 2020.
Biocon’s Glargine is approved in Australia and New Zealand while it is already selling in EU and Japan.
And in another development, the FDA completed its surveillance (routine) cGMP inspection of one of its Biologics Drug Product facilities in Bengaluru from Aug 22 to Aug 30, 2019. The inspection concluded with four observations which, the company believes will not impact supplies from this facility.