Sandoz presents highlights from Phase 3 study of Humira biosimilar
The company presented the information, which showcased the Phase 3 confirmatory efficacy, safety and immunogenicity study meeting its primary endpoint, at the American Academy of Dermatology conference in Orlando, Florida.
The endpoint of the study confirmed that GP2017 has equivalent efficacy to the reference medicine, Humira. During the study, 67 percent of patients saw a 75 percent improvement at Week 16 for the treatment of psoriasis. This compares to the 65 percent of patients with moderate to severe, chronic psoriasis that had the same response rate with the reference medicine.
“Currently, it is estimated that as few as five percent of eligible psoriasis patients get the biologics they need,” Dr. Mark Levick, global head of development of biopharmaceuticals for Sandoz, said in a statement. “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.”
In its press release, Sandoz said it remains committed to delivering better access to patients who need high-quality, life-enhancing biosimilars.