London, 7 February 2022 – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces an exclusive licensing agreement with South Korea-based Celltrion, Inc. and Celltrion Healthcare, Inc. (Celltrion) for Remsima® subcutaneous (SC), the first subcutaneous formulation of infliximab.
7 February 2022
Product, Press Release
The agreement provides Hikma with exclusive rights to commercialise Remsima® SC, the world’s first subcutaneous formulation of infliximab, in all of its MENA markets. It builds on Hikma’s existing partnership with Celltrion for three of its biosimilar products, Truxima® (rituximab), Remsima® (infliximab) and Herzuma® (trastuzumab). Remsima® SC is used in the treatment of rheumatoid arthritis and a number of other conditions.
“We are very excited to build on the success of our long-term agreement with Celltrion and add Remsima® subcutaneous to our portfolio of biosimilar products in the MENA region,” said Mazen Darwazah, Hikma’s Executive Vice Chairman and President of MENA. “Subcutaneous administration has been shown to be effective, safe, well-tolerated and generally preferred by patients. This new formulation enables administration outside of the hospital setting, allowing more patients access to the treatment. This is another example of Hikma using its capabilities to increase access to important medicines and introduce delivery systems that can improve the quality of life of patients as part of our mission to put better health within reach, every day.”
About Remsima® (CT-P13) intravenous (IV) formulation
Remsima® IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis (RA) and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.
About Remsima® CT-P13 subcutaneous (SC) formulation
A 120 mg fixed dose of Remsima® SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications for the IV formulation. Remsima® SC has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration. CT-P13 SC is currently approved in 41 countries and commercialized in 13 countries. It is approved for the treatment of patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis, and rheumatoid arthritis.
About CT-P13 (biosimilar infliximab)
CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra®. CT-P13 is approved in more than 98 countries (as of October 2021) including the US, Canada, Japan and throughout Europe.