Lannett And FDA To Meet Over Insulin Glargine Biosimilar
Follow-On To Lantus Being Developed With China’s HEC Pharm
For its proposed biosimilar to Lantus, Lannett promised in early February this year “to send the FDA our briefing book within the next few weeks and meet with them later this fiscal year to review the development plan.” The date for the meeting has now been confirmed.
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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.
Despite reporting a 16.4% drop in turnover in its financial third quarter, Lannett says it has recorded the highest quarterly sales since a key levothyroxine distribution deal fell apart last year. The company has launched 14 products in the financial year so far and plans to launch several more.
Lannett’s Phase I trial for biosimilar insulin glargine has met “all primary endpoints,” the company has announced. The rival to Sanofi’s Lantus is being developed by Lannett with partner HEC through a deal for which financial details have just been revealed.