Hikma and Celltrion Healthcare sign exclusive licensing agreement for ustekinumab for the Middle East and North Africa region

Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces a new exclusive licensing agreements with Celltrion Healthcare Co., Ltd. for CT-P43 (ustekinumab). CT-P43 is a monoclonal antibody that is a proposed biosimilar to Janssen’s Stelara^®.  

Under the terms of the agreement, Hikma will have exclusive rights to commercialise CT-P43 in all of its MENA markets and Celltrion Healthcare will develop, manufacture and supply CT-P43 to Hikma. CT-P43 is an important drug used in the treatment of autoimmune disesases such as Crohn’s disease and ulcerative colitis, and the agreement will help equip doctors and patients with more treatment options across the region. This agreement also builds on Celltrion Healthcare and Hikma’s existing partnership in MENA, adding another immunology biosimilar to Hikma’s portfolio, a key focus of its strategy.

“We are excited to add CT-P43 to our portfolio, strengthening our offering of biosimilar and innovative biologic products.” said Mazen Darwazah, Hikma’s Executive Vice Chairman and President of MENA. “CT-P43 is the sixth immunology biologic we add to our portfolio in MENA. This new addition enables us to increase patients’ access to important specialty products, helping them in their treatment journey for these difficult diseases.”

About CT-P43

CT-P43 is a biosimilar to Janssen’s Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 from binding to the IL-12Rβ1 receptor protein expressed on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. IL-12 and IL-23 have been implicated as important contributors to the chronic inflammation that is a hallmark of Crohn's disease and ulcerative colitis, among many other autoimmune diseases. Stelara^® is currently approved for the treatment of active psoriatic arthritis (PsA) in adults, alone or in combination with MTX, the treatment of patients 6 years or older with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy, the treatment of moderately to severely active Crohn’s disease (CD) in adults, and the treatment of moderately to severely active ulcerative colitis (UC) in adults.