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Lannett Advances Its Insulin Glargine

Rival To Sanofi’s Lantus Gets Positive Feedback From FDA

Executive Summary

After receiving “positive feedback” from the US Food and Drug Administration on its biosimilar insulin glargine, Lannett plans to move forward with its development activity.

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Lannett On Track To Launch Insulin Glargine By 2023

After receiving feedback from the FDA, Lannett has announced that it is on track to submit an investigational new drug application for its insulin glargine candidate to the agency later in 2021. Following this, the company plans to file a biologics license application in 2022 and launch the product in 2023.

Mylan And Biocon Launch Semglee Insulin Glargine In US

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.

Mylan And Biocon’s Semglee Insulin Glargine Approved In US

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.

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