Sanofi’s RA drug Kevzara approved in Europe

Sanofi’s next-generation rheumatoid arthritis drug Kevzara has been approved in Europe, giving a new option for patients who are intolerant to other treatments.

Kevzara (sarilumab) may be used in combination with methotrexate for moderately to severely active disease, in patients intolerant to one or more disease-modifying anti-rheumatic drugs.

Developed jointly by Sanofi and Regeneron, Kevzara may also be used as monotherapy in case of intolerance to methotrexate, or when treatment with methotrexate is inappropriate.

Sarilumab is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to block pro-inflammatory IL-6 mediated signalling. IL-6 is a protein in the body that, in excess and over time, can contribute to both the pathological inflammation and joint destruction that are associated with RA.

Kevzara was approved last month in the US, with Sanofi undercutting prices of established rivals such as AbbVie’s Humira (adalimumab) by around a third. The company is yet to confirm its European pricing, but is likely to follow this strategy.

Sandoz’s biosimilar Enbrel approved

Meanwhile, Sandoz’ Erelzi, a biosimilar of Pfizer/Amgen’s Enbrel (etanercept) has just been approved, across all the anti-inflammatory licences of the originator product.

Samsung Bioepis already has its Enbrel biosimilar Benepali on the market, but the arrival of Sandoz’s entrant is likely to drive down prices further.

Uptake of biosimilar etanercept has been patchy since its European approval early last year. Data from QuintilesIMS shows that Denmark has led uptake in Europe, with biosimilars accounting for more than 78% of treatment days, while the products have barely penetrated the market in France, Italy and Spain.

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