Celltrion USA announces submission of the Biologics License Application (BLA) of novel subcutaneous formulation of CT-P13 to U.S. Food and Drug Administration

• CT-P13 SC is a novel subcutaneous formulation of infliximab
• The Biologics License Application (BLA) submission is based on phase III pivotal data that evaluated the efficacy and safety of CT-P13 SC as maintenance therapy in patients with moderately to severely active ulcerative colitis and Crohn’s disease
• Celltrion’s CT-P13 is the first and only infliximab to have both intravenous (IV) and subcutaneous (SC) formulations; novel formulation provides an alternative administration option for physicians and their patients in the U.S.

December 22, 2022 06:21 PM Eastern Standard Time

CHICAGO--(BUSINESS WIRE)--Celltrion USA today announced the submission of a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a “stand-alone” BLA) for lead product candidate, CT-P13 SC, which is the subcutaneous formulation of infliximab to the U.S. Food and Drug Administration (FDA). The planned initial submission package will seek approval of CT-P13 SC for the treatment of inflammatory bowel disease (IBD).

“This BLA submission marks a significant milestone for Celltrion and we are working with the FDA to bring this innovative treatment to the U.S. market,” said Hyoung Ki Kim, Vice Chairman & CEO, Celltrion Healthcare. “We are committed to furthering the advancement of innovative treatments that provide improvements to clinical outcomes and drug pharmacology and reduce patients’ burden on their day-to-day lives.”

The submission is based on results from the phase III pivotal data that evaluated the efficacy and safety of CT-P13 SC as maintenance therapy in patients with moderate to severe active ulcerative colitis (UC) (LIBERTY-UC) and Crohn’s disease (CD) (LIBERTY-CD). Based on the results of the LIBERTY-UC and LIBERTY-CD studies, CT-P13 SC demonstrated superiority over placebo in maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with UC and CD respectively, over a one-year treatment period.1,2

A subcutaneous formulation has the potential to enhance treatment options for the use of the infliximab drug by providing high consistency in drug exposure and a convenient method of administration.3,4

“We’re excited about the potential of CT-P13 SC as it allows patients to have more control of their treatment, providing much better independence and convenience,” said Jaeik Shim, Chief Operating Officer, Celltrion USA. “In addition, CT-P13 SC releases the burden of having to travel to treatment for IV infusions, reducing treatment-related travel costs for patients and caregivers.”

Notes to Editors:

About the pivotal LIBERTY-UC study
The LIBERTY-UC is a randomized, placebo-controlled, double-blind, phase III study designed to evaluate the superiority of the subcutaneous CT-P13 (CT-P13 SC) in efficacy and safety during maintenance therapy in patient with moderate to severe active UC. A total of 438 patients were randomized at Week 10. The rate of clinical remission at Week 54 was significantly greater in CT- P13 SC (43.2%) compared to placebo (20.8%) (P<0.0001). The safety profile during maintenance phase was generally comparable between CT-P13 SC and placebo arms.

About the pivotal LIBERTY-CD study
The LIBERTY-CD is a randomized, placebo-controlled, double-blind, phase III study designed to evaluate the superiority of the subcutaneous CT-P13 (CT-P13 SC) in efficacy and safety during maintenance therapy in patient with moderate to severe active CD. A total of 343 patients were randomized at Week 10. At Week 54, the clinical remission rate was greater in CT-P13 SC arm than placebo arm (62.3% and 32.1% respectively, with P <0.0001). The safety profile during maintenance phase was generally comparable between CT-P13 SC and placebo arms.

About subcutaneous (SC) injection of CT-P13
CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120 mg fixed dose of CT-P13 SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications. The SC formulation has the potential to enhance treatment options for the use of the infliximab drug by providing high consistency in drug exposure and a convenient method of administration.3,4

About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed, and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us.

About Celltrion USA
Celltrion USA is Celltrion Healthcare’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to next-generation biopharmaceuticals to improve care for U.S. patients. Celltrion currently has four biosimilars approved by the U.S. FDA: Remsima® (infliximab), Truxima® (rituximab), Herzuma® (trastuzumab), and Vegzelma® (bevacizumab). Celltrion USA will continue to leverage Celltrion Healthcare’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients.

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References
1 CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC). Clinicaltrials.gov;2022. https://clinicaltrials.gov/ct2/show/NCT04205643#wrapper [Last Accessed December 2022]
2 CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD). Clinicaltrials.gov;2022. https://clinicaltrials.gov/ct2/show/NCT03945019 [Last Accessed December 2022]
3 Reinisch W et al. DOP62 A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase I open-label randomised controlled trial in patients with active Crohn’s disease, Journal of Crohn's and Colitis, Volume 13, Issue Supplement_1, March 2019, Pages S066–S067, https://doi.org/10.1093/ecco-jcc/jjy222.096
4 Westhovens R, Wiland P, Zawadzki M et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: 30-week Results from Part Two of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (SAT0170) Presented at EULAR 2019.