At the American Academy of Dermatology Annual Meeting, Sandoz announced that its proposed biosimilar adalimumab has met its primary endpoint for demonstrating efficacy in clinical trials.
The phase 3 study results found that the proposed biosimilar, GP2017, was in fact slightly more effective than the reference drug, AbbVie’s Humira. The primary endpoint was the proportion of participants with moderate to severe chronic plaque psoriasis who saw a 75% improvement in symptoms, as measured by the Psoriasis Area and Severity Index. After 16 weeks of treatment, 67% of those receiving the biosimilar achieved this benchmark, as did 65% of those on Humira.
At the end of the first 17-week study period, GP2017 had demonstrated favorable results for safety and immunogenicity, as the occurrence of adverse events and antibody reactions were similar to those observed in patients receiving the reference drug. Any adverse events were consistent with those listed in Humira’s safety profile.
Executives of Sandoz, a subsidiary of Novartis, heralded the trial data as an exciting step towards expanded access to treatment for patients with chronic plaque psoriasis.
"Currently, it is estimated that as few as five percent of eligible psoriasis patients get the biologics they need," said Mark Levick, MD, PhD, global head of development in biopharmaceuticals at Sandoz. "We are pleased the data reinforce the potential of our biosimilar adalimumab, if approved, to be another treatment option for moderate-to-severe chronic plaque psoriasis and other inflammatory diseases."
Sandoz plans to file its application for GP2017’s approval with both the European Medicines Agency and the FDA this year. The FDA filing was originally intended for the last quarter of 2016, but was pushed back due to concerns about the timing of regulatory inspections in conjunction with manufacturing facility upgrades, according to Novartis executives. Chief medical officer Vasant Narasimhan denied that the delay was due to any unfavorable clinical data for the proposed biosimilar.
GP2017 will be racing against another competitor, Coherus’s CHS-1420, as it travels through the development and approval pipeline. Less than a week ago, Coherus announced that its proposed adalimumab biosimilar achieved pharmacokinetic (PK) equivalence with the reference drug in clinical trials and had demonstrated comparable safety and tolerability profiles.
The president and CEO of Coherus, Danny Lanfear, said that the drug maker is confident it can “similarly complete future PK studies with modified formulations, anticipated to commence later in 2017.” He did not specify a timeline for submitting a regulatory application.
There is currently just 1 FDA-approved biosimilar for autoimmune drug adalimumab, Amgen’s Amjevita, but its launch has been held up by patent lawsuits from AbbVie. One analysis in 2015 reported that a yearlong course of AbbVie’s Humira cost an average of $27,665 after discounts, an increase of almost 50% from its cost 3 years prior.