US Marks Biologics Transition Day
FDA Sees 96 Drugs Make The Move To Biologics Regulation
Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.
You may also be interested in...
A draft Biosimilar Insulin Access Act, intended to waive US interchangeability requirements for FDA-approved biosimilar insulins, has been introduced by representative Glenn Grothman.
The US FDA’s ‘Purple Book’ which was created “to improve transparency and functionality for stakeholders by providing a complete view of biological product options” has been updated after being recently transitioned into an online database.
Mylan and Biocon have received FDA approval for their Semglee insulin glargine product, with a path to market seemingly clear after Mylan emerged victorious in several recent patent-litigation challenges. Meanwhile, the firm continues to strive towards an interchangeability designation that would make it a much more valuable opportunity.