$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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.