Baxalta and Coherus report positive data from etanercept biosimilar trial

Baxalta and Coherus BioSciences have announced new clinical data demonstrating the safety and efficacy of their new biosimilar version of the anti-TNF therapy etanercept.

CHS-0214, the companies' investigational biosimilar version of Enbrel, has met its primary endpoint in a two-part clinical study assessing the drug among moderate-to-severe rheumatoid arthritis patients who have failed to respond to methotrexate alone.

The study will now continue as planned until week 52. It is the second of two large phase III confirmatory trials intended for inclusion in global marketing applications for CHS-0214.

Results from the first of these studies were made public in November 2015 and demonstrated the drug's effectiveness in patients with chronic plaque psoriasis, with this first trial also meeting its primary endpoints.

Dagmar Rosa-Bjorkeson, executive vice-president and president of biosimilars at Baxalta, said: "This important clinical milestone, adding to previously announced positive data in patients with chronic plaque psoriasis, brings us one step closer to expanding treatment options for patients."

Earlier this week, it was confirmed that Baxalta will soon be merging with Shire, a deal that will create a new industry leader in the field of rare diseases.