$599
Thoughts on Biocon Form 483 Observations and Impact to Semglee US Launch
Biocon has reportedly received six Form 483 observations during FDA’s pre-approval inspection of its insulin drug substance manufacturing facility in Bengaluru (Bangalore); however, this Form 483 is not yet listed in FDA’s public database. Interestingly, the Biocon press release states the FDA inspection was “triggered by a New Drug Application submitted by our insulin API customer” which is assumed to be referencing the bs-glargine filing by Mylan. Below, FENIX provides insight on the impact to the Semglee (glargine U100) US commercial launch and thoughts on how a delayed tentative approval could potentially lead to a royalty agreement between Sanofi and Mylan.