MYL-1601D (insulin aspart)

MYL-1601D Approval Pending

MYL-1601D (insulin aspart)

MYL-1601D Approval Pending

U.S. License Holder:

Viatris / Biocon

Date of License:

aBLA accepted by FDA 2021, Complete Response Letters January-2022, October-2023

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

MYL-1601D (insulin aspart) is not FDA-approved. An aBLA has been submitted to the FDA.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Kirsty (BGP Pharma (Viatris)) (October-2021)

Biosimilars Approved In The E.U.

Kirsty (previously Kixelle) (Viatris / Biocon) (February-2021)

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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