Gan and Lee + Sandoz and FDA Biosimilar Insulin BLA List
Today, Sandoz announced it has in-licensed the biosimilar insulin portfolio of Gan & Lee for commercialization of glargine, aspart, and lispro. Last week, FDA published a Q&A document and a list of biologics that will convert from NDA to BLA under the US BPCI Act of 2010, which include insulin products. Below, FENIX briefly provides thoughts on each topic.
About The Author
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. Log in now
You can read the article’s full content online after purchase.