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Sandoz joins Europe's MabThera biosimilar push

Novartis’ unit is second company to claim approval in Europe for biosimilar version

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Novartis' Sandoz unit has become the second company to claim approval in Europe for a biosimilar version of Roche's blockbuster immunotherapy drug MabThera.

The approval - which comes four months after Celltrion/Mundipharma's Truxima biosimilar was cleared for marketing by the EMA - is for the entire range of indications awarded to MabThera, including non-Hodgkin's lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis.

Sandoz will sell its biosimilar under the Rixathon/Riximyo brand names, and the firm's biopharma head, Carol Lynch, said the approval is "a big win for patients in Europe with blood cancers or immunological diseases because it enables increased access to biologics".

Having another biosimilar on the market "will allow healthcare systems to redeploy resources to other areas of high need, particularly innovative therapies," she added.

There is no word on pricing for Rixathon just yet, but biosimilars typically sell at a 10-30% discount compared to their branded equivalents, although in some cases - such as biosimilars of Johnson & Johnson's Remicade (infliximab) - the reductions have been up to 60%.

MabThera is celebrating its 20th year on the market this year, and has been a massive earner for Roche over that period.  Sales of the drug - known as Rituxan in some markets, including the US - are thought to be at their peak, coming in at a little under $7.5bn in both 2015 and 2016 despite increasing competition and pricing pressure.

Biosimilars that are currently on the market are predicted by EvaluatePharma to lose around $4.5bn over the next five years. Most of that impact will be felt after biosimilars appear in the US, however, which Roche says it does not expect until after 2019. Sandoz has indicated it will file its biosimilar in the US later this year.

Truxima claimed the distinction of being the first biosimilar cancer drug to reach the market in Europe, having already been launched in various markets in Asia and Latin America, and analysts have predicted that sales of the drug could reach $335m by 2022.

Sandoz will be hoping its marketing muscle will help it close the gap on the leader as it builds its portfolio of biosimilars - currently four products in Europe which it says is more than any other company. Meanwhile, a third biosimilar version of MabThera - from Mylan/Mabion – is scheduled to be filed with the EMA before the end of the year.

Article by
Phil Taylor

19th June 2017

From: Regulatory

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