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Roche faces prospect of second Rituxan biosimilar in US

FDA begins its review of Sandoz's version of the immunotherapy treatment

Roche

The US Food and Drug Administration (FDA) has started its review of a second biosimilar rival to Roche's blockbuster immunotherapy drug Rituxan, with Novartis' Sandoz unit seeking to dent its Swiss rival’s sales.

Rituxan is used to treat blood cancers including non-Hodgkin's lymphoma and chronic lymphocytic leukaemia, as well as immunological diseases such as rheumatoid arthritis, and is Roche's biggest-selling product with sales of 3.84bn Swiss francs ($4bn) in the first six months of the year, more than half from the US. It lost patent protection in the US in 2016.

Sandoz' version – which was approved in Europe under the Rixathon brand name in June – has been filed based on a study looking at the drug's pharmacological profile in rheumatoid arthritis and a confirmatory safety and efficacy study in follicular lymphoma.

It was the second biosimilar of Roche's drug to be approved in Europe after Celltrion/Mundipharma's Truxima, which also pipped Sandoz to the filing post in the US after being filed by Celltrion and US partner Teva in June.

Sandoz' global head of biopharma development Mark Levick said: "The cost of treating cancer in the US is a major concern for many patients and their families as well as for the healthcare system.

"We plan to deliver patients a high-quality Sandoz biosimilar that, following approval, could help drive healthcare savings and increase competition, while freeing up resources for and supporting patient access in other areas of cancer care including innovative therapies."

Roche is fighting back against the biosimilars with a new formulation of Rituxan, claiming FDA approval in June for Rituxan Hycela (rituximab and hyaluronidase) – which can be given by subcutaneous injection rather than intravenous infusion – for the treatment of adults with some forms of blood cancer. It shortens the administration time from 1.5 hours to only a few minutes.

Rituxan is not the only one of Roche's big-selling biologic drugs to be under threat of biosimilar competition, with second and third top-sellers Herceptin (trastuzumab) and Avastin (bevacizumab) also vulnerable. In July, an FDA advisory committee backed biosimilars of both those drugs.

Sandoz has five biosimilars already on the market worldwide, and says it plans to launch five more oncology and immunology biosimilars between 2017 and 2020.

Article by
Phil Taylor

13th September 2017

From: Regulatory

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