Lannett Kicks Off Insulin Glargine Trial
Firm Eyes 2023 Filing And 2024 Launch For US Interchangeable Biosimilar Lantus Rival
Lannett has delivered on its promise of kicking off a pivotal clinical trial for its proposed interchangeable biosimilar rival to Lantus by the end of March, as it eyes a 2023 filing and 2024 launch in the US for the insulin glargine product on which it has partnered with HEC.
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Lannett once again saw its sales and profits hit by “ongoing competitive pressures” as well as a high rate of product returns in its financial third quarter. However, the company is banking on several major long-term pipeline opportunities, as well as a handful of nearer-term launches, to reverse its decline.
A further voluntary recall for Viatris’ insulin glargine biosimilar, this time for one of its recently launched interchangeable products, because of missing labels may draw unwanted interest from the US FDA, a leading analyst has warned.
US-based manufacturer Lannett has received a notice of non-compliance from the NYSE due to price of the company’s share. Lannett insists there is no immediate impact, but the firm is evaluating options, including “transactions that are subject to approval of Lannett’s stockholders.”