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Novartis receives European biosimilar approval for Roche blockbuster

Published on 19/06/17 at 09:04am

Sandoz, a division within Novartis, has received European Commission approval for its biosimilar version of Roche’s Rituxan (also known as MabThera). Rituxan garnered Roche $7.5 billion in global sales last year and this latest approval adds another challenge to Roche core drug sales.

Rixathon, the name of Novartis’ biosimilar, comes after Celltrion’s approval for its Truxima in February and, with a further five biosimilar Rituxan applications going through the European commission, the drug looks set to face serious competition.

"Today's approval of Rixathon represents a big win for patients in Europe with blood cancers or immunological diseases because it enables increased access to biologics. It also allows healthcare systems to redeploy resources to other areas of high need, particularly innovative therapies" said Carol Lynch, Global Head, Biopharmaceuticals, Sandoz. "Sandoz is committed to increasing patient access to biologic medicines, and Rixathon will be one of the five major launches we plan in the next four years. We have worked with care and passion towards this approval, and now is the time when we are bringing this medicine to healthcare professional and patients in Europe."

As mentioned by Lynch, the approval means that there will be another lower-cost option for healthcare systems to use as an alternative to Rituxan. Novartis aim to file for approval of its biosimilar in the US later this year.

For its part, Roche is set to be hit by further applications to its core range of drugs, including Rituxan, Herceptin and Avastin – the combined sales total of which are worth over $20 billion in sales to the company.

Investors are not unduly worried by the turn of events that has been long predicted. Roche have prepared well for biosimilar competition, protecting its drugs with patents up to the hilt and diversifying its portfolio, such as with Ocrevus – a treatment for multiple sclerosis.

Ben Hargreaves

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