Kevzara Earns European Approval, Puts Further Pressure on Humira

Today, Sanofi and Regeneron announced that the European Commission (EC) has granted marketing authorization for the companies’ sarilumab (Kevzara), which is approved to treat severely active rheumatoid arthritis (RA) in adult patients who have either not tolerated or not responded adequately to disease modifying anti-rheumatic drugs (DMARDs). Sarilumab, which may be used jointly with methotrexate or as a monotherapy in patients who do not tolerate methotrexate, is also approved in the United States.

The EC’s approval of the human monoclonal antibody was based upon a positive opinion delivered by the European Medicine Agency’s Committee for Medicinal Products for Human Use, which evaluated results from 7 phase 3 trials that incorporated data from more than 3300 adults with moderately to severely active RA.

These trials included a phase 3 study that compared sarilumab monotherapy to adalimumab (AbbVie’s Humira) monotherapy; at 24 weeks of treatment, patients treated with sarilumab monotherapy demonstrated greater reduction in disease activity, greater improvement in baseline physical function, higher rates of remission, and greater improvement in the signs and symptoms of RA than did patients treated with adalimumab monotherapy.

In addition to news that sarilumab outperformed Humira in this trial, Sanofi and Regeneron have announced that the drug’s US list price of $39,000 represents a savings of roughly 30% relative to Humira and etanercept (Amgen’s Enbrel). The manufacturers are expected to adopt a similarly competitive pricing strategy in Europe in order to help increase sarilumab’s market share.

Such a move could put additional pressure on AbbVie, which has so far held dominance in the crowded anti-rheumatic drug market, to adjust the price of its blockbuster RA drug, Humira. Deemed cost-ineffective by the Institute for Clinical and Economic Review, Humira was responsible for 63% of AbbVie’s 2016 revenue, though challenges from biosimilar adalimumab treatments are expected to erode its earnings in the coming years. While AbbVie seeks new inroads into the RA marketplace with such innovative drugs as its upadacitinib (ABT-494), AbbVie will be unable to rely on that drug’s prospective launch alone. The manufacture will have to develop strategies to better compete with small-molecule and biosimilar drugs alike in an increasingly crowded RA landscape.