Merck KGaA, Darmstadt, Germany, a top technology and science company, recently announced that it has launched its worldwide phase-three clinical study of MSB11022, which is a proposed biosimilar containing adalimumab, to determine whether it is helpful in treating inflammatory diseases like chronic plaque psoriasis.
This phase is a testimony to the company’s progress made in developing biosimilars. The company’s goal is to provide patients around the world with high-quality biologics.
This double-blind, randomized, active-controlled study will determine the safety, efficacy and immunogenicity of the adalimumab biosimilar candidate MSB11022 as compared to Humira. The test subjects include patients who have moderate to severe chronic plaque psoriasis.
Humira, which AbbVie Inc. markets around the world, is currently the main treatment for chronic inflammatory conditions. The researchers hope to determine the usefulness of the new candidate against rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, juvenile idiopathic arthritis and Crohn’s disease.
"With the first patient now being treated in our adalimumab biosimilar candidate study, we are moving closer to expanding access to affordable, high-quality biologics for people living with serious diseases," Michael Soldan, head of biosimilar business for Merck KGaA, said. "At the same time, this milestone supports our broader health care strategy to complement our innovative R&D pipeline with biosimilars that serve as important therapeutic options for patients in need."