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Biosimilar Lantus leads CHMP opinions

Boehringer and Lilly’s insulin one of six new medicines recommended for EU approval

Six new medicines have received backing for use in the EU by the advisory body to the European Medicines Agency (EMA).

Leading the pack is Abasria, a biosimilar version of Sanofi's huge-selling insulin glargine Lantus, which is recommended to treat people with both type 1 and type 2 diabetes who are unable to control blood sugar levels.

Abasria was developed by Boehringer Ingelheim and Lilly and is the first biosimilar insulin to be recommended by the Committee for Medicinal Products for Human Use (CHMP).

The decision opens the door for Lilly and Boehringer to offer a direct challenge to Sanofi once Lantus' patent expires in the next couple of years. Once launched it could make a serious dent in Lantus revenues, which peaked at more than $7bn last year, making it the seventh highest grossing drug in the world.

Sanofi is not lying still though and has a new version of Lantus in the works, called Toujeo, which has a reduced risk of hypoglycaemia. Speaking to PMLiVE at this month's American Diabetes Association meeting, Sanofi's Pierre Chancel confirmed the company plans to push for doctors to switch from Lantus to Toujeo.

Recommendations in hepatitis C and HIV

Other significant recommendations by the CHMP included Bristol-Myers Squibb's (BMS) Daklinza (daclatasvir), which was backed for use as a treatment for chronic hepatitis C.

It is one of several new oral therapies that are transforming the still problematic hepatitis C market. Gilead Sciences' Sovaldi (sofosbuvir) is emerging as the leader in the field, although there is further competition from Janssen and Merck & Co.

ViiV Healthcare, a joint venture between GlaxoSmithKline, Pfizer and Shionogi, also scored a recommendation in infectious diseases.

Triumeq – a combination of already-approved treatments Tivicay (dolutegravir) and Kivexa (abacavir/lamivudine) – was recommended to treat HIV infection in adults and adolescents aged 12 years and older. It gives patients a more convenient single-tablet option.

Elsewhere, the CHMP also backed a combination of Clopidogrel and acetylsalicylic acid to be marketed by Teva for the prevention of atherothrombotic event.

In addition GE Healthcare received a positive opinion for Vizamyl (flutemetamol) as a diagnostic for Alzheimer's disease. Vizamyl is a biomarker that can detect amyloid-beta neuritic plaques, where are formations in the brain associated with Alzheimer's.

The final new medicine recommended for use in the EU is Velphoro (sucroferric oxyhydroxide), to be marketed by Vifor Fresenius Medical Care Renal Pharma. The drug is recommended to control levels of serum phosphorus levels in adult patients with chronic kidney disease on haemodialysis or peritoneal dialysis.

Article by
Thomas Meek

30th June 2014

From: Sales, Regulatory



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