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Bioequivalency

Insulin

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

FEBRUARY 8, 2021

Last year, Biocon Biologics and Mylan announced they’d be seeking interchangeable status for their long-acting insulin product Semglee , developed to be an alternative to Sanofi’s Lantus (insulin glargine). Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product.

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Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. Additionally, the Company sells insulin API products. ” According to IQVIA, the U.S.

Bioequivalency

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

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