US Bill Urges Automatic Insulin Interchangeability
Representative Glenn Grothman Introduces Biosimilar Insulin Access Bill
A draft Biosimilar Insulin Access Act, intended to waive US interchangeability requirements for FDA-approved biosimilar insulins, has been introduced by representative Glenn Grothman.
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Biocon Biologics upbeat on Lantus follow-on’s long revenue stream and prospects for interchangeability, while operational challenges resulted in some supply constraints during the fiscal second quarter.
Mylan and Biocon have launched their Semglee version of insulin glargine in the US, revealing pricing details for the Lantus rival. At the same time, the firms have offered an update on their attempts to have Semglee classified as a biosimilar as they seek an interchangeability designation.
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.