Humalog® (insulin lispro recombinant)

BL 020563

Humalog® (insulin lispro recombinant)

BL 020563

U.S. License Holder:

Eli Lilly

Date of License:

June-14-1996

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

HUMALOG (insulin lispro recombinant) is a rapid acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

approved_indications aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Approved by FDA

Admelog®: Sanofi-Aventis (December-2017) Insulin Lispro (Authorized Generic) (Eli Lilly / ImClone) (March-2019)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Admelog® (Sanofi) (July-2017)

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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