FDA Suggests Filing IND for Insulin Glargine

Karyo Biologics' advanced program insulin glargine, eligible for filing under 505 B(2), has been reviewed by FDA in detail and the FDA has suggested that "we see no reason why karyo cannot file an IND." This is a great step for Karyo. The FDA has also allowed Karyo several concessions regarding the batch size and testing protocols, all intended to expedite the filing of IND. Karyo is also pleased to announce several major partnerships with CMOs and CROs in the US to help Karyo file its first IND soon. Once the IND is approved, Karyo will enter into licensing agreement with a commercial partner, making this the first-ever private label biosimilar offering in the USA. The cost of FDA approval has been finalized and comes to a record low compared to similar products approved recently. For more information please connect niazi@karyobio.com. Insulin glargine has hit $8+ Billion in 2017 and growing faster than Humira. Eli LIlly is the first holder of approved biosimilar insulin glargine.