Celltrion's Remsima SC scores marketing authorization in New Zealand

Celltrion said on Friday that it received marketing authorization from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for its autoimmune disease treatment, Remsima SC (ingredient: infliximab).

Celltrion received marketing authorization for the full range of 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.

Previously in 2015, Celltrion obtained the product license for Remsima IV (intravenous injection type) in New Zealand, and then received the license for Remsima SC (hypodermic injection type), strengthening its competitiveness in the local autoimmune disease treatment market.

With approvals in Australia and New Zealand, the company plans to expand across Oceania to further increase its market share and influence.

As the world's first subcutaneous formulation of infliximab, Remsima SC is Celltrion's next strategic product with improved patient convenience which continues to gain share in Europe.

According to IQVIA and Celltrion Healthcare, Remsima SC has achieved a 16.1 percent market share in the five largest European countries which refers to France, Germany, Italy, Spain, and the United Kingdom, as of the fourth quarter of last year.

Additionally, Celltrion completed the new drug application (NDA) for Remsima SC and expects to obtain FDA approval in October this year.

"With a variety of clinical data demonstrating efficacy and safety, as well as patient convenience, we will do our best to continue to expand the global market for Remsima SC," said a Celltrion official.