Celltrion "RamsimaSC Accelerates Global Patent Acquisition... Plans FDA Approval Application in the US Within the Year"

Celltrion Remsima SC. [Photo by Celltrion]

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 30th that it is establishing a stable revenue protection foundation through efforts to secure global patents for its autoimmune disease treatment 'RemsimaSC.'

Considering that RemsimaSC is the world's first subcutaneous (SC) formulation of infliximab, Celltrion has proactively filed patents on the formulation and administration method of RemsimaSC in major countries such as the United States, Europe, and Asia since 2018.

The RemsimaSC formulation patents have been registered and granted in countries including South Korea, Australia, and Taiwan, and sales approvals have also been obtained in these countries, securing conditions for stable market entry.

The patents filed by Celltrion are barrier patents designed not only to protect RemsimaSC but also to defend against market entry of infliximab subcutaneous biosimilars, representing a proactive defense for product protection. Celltrion expects that once the patents are registered, they will maintain RemsimaSC's exclusive status until expiration, creating a foundation for stable profit generation.

Celltrion anticipates that patents will also be sequentially registered in the United States and European countries, where examinations are currently underway. Upon registration after examination, the formulation patent of RemsimaSC will be protected until June 2037, and the administration method patent until August 2038.

Additionally, Celltrion recently demonstrated the efficacy and safety of RemsimaSC in a global Phase 3 clinical trial conducted for entry into the U.S. market and plans to submit an approval application to the U.S. Food and Drug Administration (FDA) within this year.

A Celltrion official stated, "We will do our best to complete the remaining patent registrations to ensure RemsimaSC firmly establishes itself in major global markets and to build a stable revenue protection foundation."

This content was produced with the assistance of AI translation services.