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Payback time nears as Sanofi gets CHMP backing for biosimilar Humalog

Panel recommends insulin Lispro Sanofi to treat diabetes

EMASanofi's biosimilar version of Eli Lilly's mealtime insulin product Humalog has been recommended for approval in the EU, raising the prospect of further pressure on Lilly's top-selling product.

The Committee for Medicinal Products for Human Use (CHMP) gave the go-ahead for Sanofi's version of insulin lispro - the active ingredient in Humalog - as well as three other biosimilars at its monthly meeting late last week.

The recommendation is sweet for Sanofi giving it an opportunity to turn the tables on Lilly, which recently bagged approval for its biosimilar of Sanofi's long-acting insulin blockbuster Lantus (insulin glargine) in Europe and the US.

The panel recommended the use of the biosimilar - called insulin lispro Sanofi - to treat adults and children who have diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed. The French drugmaker said it was its "first major regulatory milestone for a biosimilar diabetes treatment".

The importance of Humalog to Lilly cannot be overstated particularly as biosimilar competition is looking on most major markets between now and 2019. The drug brought in $2.8bn last year, a small decline on 2015 but bounced back in the first quarter of 2017 with sales of $708m, substantially ahead of analyst expectations.

Lilly had sought to protect its franchise by developing a new formulation of Humalog using a protein delivery technology owned by Adocia but abandoned the project and terminated its partnership earlier this year.

Meanwhile among other positive opinions granted by the CHMP was one for Leo Pharma's interleukin-17 inhibitor Kyntheum (brodalumab) - acquired from AstraZeneca - for plaque psoriasis. Valent claimed a US approval for this drug last year.

Gedeon Richter got the nod for Reagila (cariprazine) as a treatment for schizophrenia - which follows US approval in 2015 - and Chiesi picked up an approval for a three-drug combination for chronic obstructive pulmonary disorder (COPD) called Trimbow (beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium).

Dompé Farmaceutici's Oxervate (cenegermin) was recommended for the treatment of moderate to severe neurotrophic keratitis, and there was also a positive opinion for an advanced therapy medical product (ATMP) - Co Don Ag's cell-based Spherox for cartilage defects in the knee. The CHMP also backed three biosimilars of Roche's Rituxan (rituximab) developed by Celltrion namely Blitzima, Tuxella and Ritemvia.

A final decision from the European Commission usually takes around 60 days after CHMP delivers a positive opinion on a drug.

Article by
Phil Taylor

22nd May 2017

From: Regulatory

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