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MSD’s Lantus biosimilar given conditional FDA approval

Published on 21/07/17 at 09:09am

MSD, known as Merck in North America, has been granted approval for its biosimilar of Sanofi’s diabetes treatment, Lantus. Potentially, this could see MSD’s product take a slice of the $6.6 billion in sales that Lantus achieved in 2016.

However, there is a hitch to the good news for MSD, it is dependent upon a patent infringement lawsuit brought against them by Sanofi. Under the Hatch-Waxman Act, the case means that there is currently a 30 months hold placed on the product reaching market until a decision one way or the other by a court.

This is why the approval is conditional, as the resolution of the lawsuit in MSD’s favour could allow them to bring its biosimilar to market immediately.

MSD’s product would not be the first biosimilar to enter the market as competition to the originator, with Eli Lilly and Boehringer Ingelheim’s Basalgar already entering the market. MSD’s will be hoping to avoid the outcome of the patent result in this case, as the two companies were forced to pay a percentage of royalties on sales.

Basalgar entered the market at a discount of 15%, managing sales of $86.1 last year – but, as the product was approved in December 2016, it had little time to make an impact.

The product itself is an insulin glargine injection, a long-lasting version of human insulin, and will be marketed under the brand name Lusduna Nexvue.

“The tentative approval of Lusduna Nexvue is an important milestone, bringing us closer to offering this medicine to patients,” said Sam Engel, Associate Vice President of Merck Clinical Research.

For Sanofi, the approval further challenges the sales of a product that generates approximately a sixth of its total sales. The company has acted proactively to counter the threat though, already releasing a next-generation product to takeover sales, in the form of Toujeo. This product has already seen sales reach $133 million in the first quarter of this year.

Ben Hargreaves

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