Positive trial results for Lannett’s insulin biosimilar

Biosimilars/Research | Posted 17/01/2020 post-comment0 Post your comment

US firm Lannett has completed a successful trial of their candidate insulin biosimilar, which was compared to Sanofi’s blockbuster insulin product Lantus.

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Prices for insulin in the US have been notoriously unaffordable. The US Food and Drug Administration (FDA) recently noted that insulin list prices can increase by double digits each year, price rises that ‘have raised serious concerns about the ability for many patients to access the insulin needed to survive’ [1].

High prices for insulin have led to a number of initiatives, including the launch of a lower priced insulin biosimilar from Eli Lilly [2] and an insulin prequalification programme from the World Health Organization (WHO) [3].

In recent news, US firm Lannett has announced positive results from the clinical trial of their insulin biosimilar. The trial was the first clinical study in humans to directly compare Lannett’s insulin glargine biosimilar to Lantus (marketed by Sanofi).

The trial involved administering a single subcutaneous dose of the drug in 27 healthy male volunteers. The results showed that the biosimilar was well tolerated and matched the reference product in terms of pharmacokinetics, pharmacodynamics and safety.

‘In a relatively short amount of time, we have built an impressive and significant amount of data that supports the biosimilarity of our insulin glargine product to the reference drug’, said Kristin Arnold, Lannett's Vice President of Research and Development.

CEO of Lannett, Tim Crew, said the data will allow them to progress to FDA approval: ‘We expect to meet with FDA in the coming months to plan next steps for the clinical advancement of our product, including the design of the biosimilar product development plan’.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA to hold public meeting on access to affordable insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 17]. Available from: www.gabionline.net/Biosimilars/General/FDA-to-hold-public-meeting-on-access-to-affordable-insulin
2. GaBI Online - Generics and Biosimilars Initiative. Eli Lilly launches lower-priced insulin lispro [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 17]. Available from: www.gabionline.net/Biosimilars/General/Eli-Lilly-launches-lower-priced-insulin-lispro
3. GaBI Online - Generics and Biosimilars Initiative. WHO launches insulin prequalification programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 17]. Available from: www.gabionline.net/Biosimilars/General/WHO-launches-insulin-prequalification-programme

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Source: Lannett

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