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EMA’s CHMP recommends Sanofi’s Humalog biosimilar

pharmafile | May 22, 2017 | News story | Manufacturing and Production, Sales and Marketing Eli Lilly, Humalog, Sanofi 

Sanofi has received a positive recommendation by the CHMP for its biosimilar to Eli Lilly’s Humalog. The recommendation for approval indicates that the biosimilar stands a good chance of being approved across Europe for patients with diabetes.

The recommendation gives approval for the biosimilar to be used in the treatment of both adults and children with diabetes. There is potential for the biosimilar to eat significantly into the European profit margins of Humalog, Eli Lilly’s biggest selling diabetes drug. Only last month, the company posted the positive growth in sales of the product – with worldwide sales rising by 17% to $708.4 million.

With a possible biosimilar introduction coming in the coming months, Lilly will have to deal with the resulting loss in sales. Though Sanofi will feel it is poetic justice, after Lilly had gained approval for its own biosimilar to Sanofi’s long-acting insulin product, Lantus.

“We welcome the CHMP positive opinion for Insulin lispro Sanofi and look forward to the final decision of the European Commission,” said Jorge Insuasty MD, Senior Vice President, Global Head of Development, Sanofi. “Our development of this investigational biosimilar product reflects Sanofi’s expertise and long-term heritage in developing and manufacturing high-quality insulins for people with type 1 or type 2 diabetes and their physicians.”

Alongside Sanofi’s biosimilar, the CHMP also positively recommended four new medicines, three other biosimilars, six extended therapeutic indications and one generic drug for use in the treatment of HIV.

One of the four new medicines is LEO Pharma’s Kyntheum (brodalumab), a treatment for moderate to severe plaque psoriasis. The recommendation was based on three large-scale studies of patients, with a total of 4,373 involved in the trials. Success rates were found to be double those of the comparative treatment (ustekinumab), as 44% were found to have completely clear skin after treatment again 22% taking the comparative medicine.

Ben Hargreaves

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