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Samsung Bioepis wins CHMP nod for second Humira biosimilar

In addition to Imraldi the regulatory advisors also backed new medicines from AbbVie and Gilead

pharma biosmilars

The biosimilar assault in the EU on AbbVie's Humira - the biggest-selling drug in the world - has stepped up with a second candidate now recommended for approval.

Samsung Bioepis has been awarded a positive option from the Committee for Medicinal Products for Human Use (CHMP) for its Humira biosimilar - known as Imraldi - three months after Amgen won EU approval for its Amgevita version.

Like Amgen, Samsung Bioepis has got the green light for all of Humira's approved indications in Europe, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis. It is the company's third anti-TNF biosimilar in Europe after Benepali (etanercept) and Flixabi (infliximab), both of which were approved by the EMA in 2016.

Amgevita and Imraldi are not expected to be launched until AbbVie's patents expire, which should occur in October 2018. Humira made more than $16bn in sales for AbbVie last year, with around a third of that total coming from outside the US. In the US AbbVie is claiming intellectual property protection to 2032, although its base patent on the drug expired last year.

Hep C and cancer medicines also backed

All told the CHMP backed eight new medicines for approval at its meeting ahead of the weekend, including two drugs for chronic hepatitis C virus (infection) - AbbVie's Maviret (glecaprevir/pibrentasvir) and Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir).

The CHMP notes that "both Maviret and Vosevi are active against all genotypes of the virus and with some differences between the two medicines, may be specifically useful in some patients who failed or cannot use previously available therapies".

Both were reviewed under the accelerated assessment protocol because despite the robust efficacy of current drugs such as Gilead's Harvoni (sofosbuvir/ledipasvir) and AbbVie's Viekira (ombitasvir/paritaprevir/ritonavir and dasabuvir) "there is still a need for a range of alternative treatment options to serve the different medical needs of the millions of people suffering from the disease".

Two cancer medicines also received a positive opinion from the CHMP. Novartis' CDK4/6 inhibitor Kisqali (ribociclib) got the nod for the treatment of locally advanced or metastatic breast cancer - three months after getting FDA approval in breast cancer - while Eusa Pharma got the okay for VEGF receptor inhibitor Fotivda (tivozanib) for the treatment of advanced renal cell carcinoma. Tivozanib - originally developed by Aveo Pharma - was turned down by the FDA in 2013.

Article by
Phil Taylor

26th June 2017

From: Regulatory



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