Celltrion "Remsima SC Obtains Product Approval in New Zealand Following Australia"

"Will Create Synergy with Remsima"

Celltrion announced on the 9th that it has obtained marketing authorization for the autoimmune disease treatment drug RemsimaSC from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE).

Remsima SC.
Photo by Celltrion

Celltrion received marketing authorization for all indications approved for the original drug Remicade in New Zealand, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult Crohn's disease, and adult ulcerative colitis. Following the approval of the intravenous (IV) formulation RemsimaIV in New Zealand in 2015, Celltrion has now also obtained approval for the subcutaneous (SC) formulation RemsimaSC, thereby strengthening its competitiveness in the New Zealand autoimmune disease treatment market.

With this approval, Celltrion expects to expand its presence in the Oceania market. Having secured approval in New Zealand following Australia, the company plans to extend its market reach throughout Oceania to increase market share and influence. Previously, Celltrion obtained approval for RemsimaSC in Australia in 2020.

RemsimaSC is the world's first infliximab subcutaneous injection formulation and is a strategic product by Celltrion designed to improve patient convenience. According to IQVIA, a pharmaceutical market research firm, and Celltrion Healthcare, which handles distribution, RemsimaSC achieved a 16.1% market share in the five major European countries as of the fourth quarter of last year. Additionally, Celltrion completed its new drug application to the U.S. Food and Drug Administration (FDA) at the end of last year for the U.S. market entry of RemsimaSC. The company expects to obtain U.S. approval by October.

A Celltrion representative stated, "Following Australia, obtaining approval for RemsimaSC in New Zealand strengthens the competitiveness of Celltrion's autoimmune disease treatments in the Oceania region," adding, "We will do our best to continuously expand the global market for RemsimaSC, which has proven efficacy and safety in various clinical data and offers patient convenience."