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Lannett And FDA To Meet Over Insulin Glargine Biosimilar

Follow-On To Lantus Being Developed With China’s HEC Pharm

 
• By Dean Rudge

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.

Lantus
Lannett has ambitious goals to become a $1bn company, fuelled by launches like biosimilar Lantus • Source: Shutterstock

The design and endpoint of any additional human studies required for filing a biologics license application are expected to be included in a discussion Lannett will have with the US Food and Drug Administration on 9 June about the US-based firm’s biosimilar insulin glargine candidate.

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