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Celltrion USA declares submission of the Biologics License Software (BLA) of novel subcutaneous formulation of CT-P13 to US Meals and Drug Administration

CHICAGO–(BUSINESS WIRE)–Celltrion USA at this time introduced the submission of a Biologics License Software (BLA) underneath the 351 (a) pathway of the Public Well being Service Act (a “stand-alone” BLA) for lead product candidate, CT-P13 SC, which is the subcutaneous formulation of infliximab to the US Meals and Drug Administration (FDA). The deliberate preliminary submission bundle will search approval of CT-P13 SC for the remedy of inflammatory bowel illness (IBD).

This BLA submission marks a big milestone for Celltrion and we’re working with the FDA to carry this modern remedy to the US market,” mentioned Hyoung Ki Kim, Vice Chairman & CEO, Celltrion Healthcare. “We’re dedicated to furthering the development of modern therapies that present enhancements to scientific outcomes and drug pharmacology and scale back sufferers’ burden on their day-to-day lives.”

The submission is predicated on outcomes from the part III pivotal information that evaluated the efficacy and security of CT-P13 SC as upkeep remedy in sufferers with average to extreme energetic ulcerative colitis (UC) (LIBERTY-UC) and Crohn’s illness (CD) ( LIBERTY-CD). Based mostly on the outcomes of the LIBERTY-UC and LIBERTY-CD research, CT-P13 SC demonstrated superiority over placebo in upkeep remedy after induction remedy of intravenous formulation of infliximab in sufferers with UC and CD respectively, over a one-year remedy interval.1,2

A subcutaneous formulation has the potential to boost remedy choices for the usage of the infliximab drug by offering excessive consistency in drug publicity and a handy technique of administration.3.4

We’re excited in regards to the potential of CT-P13 SC because it permits sufferers to have extra management of their remedy, offering significantly better independence and comfort,” mentioned Jaeik Shim, Chief Working Officer, Celltrion USA. “As well as, CT-P13 SC releases the burden of getting to journey to remedy for IV infusions, decreasing treatment-related journey prices for sufferers and caregivers.”

Notes to Editors:

In regards to the pivotal LIBERTY-UC examine

The LIBERTY-UC is a randomized, placebo-controlled, double-blind, part III examine designed to judge the prevalence of the subcutaneous CT-P13 (CT-P13 SC) in efficacy and security throughout upkeep remedy in affected person with average to extreme energetic UC. A complete of 438 sufferers had been randomized at Week 10. The speed of scientific remission at Week 54 was considerably increased in CT-P13 SC (43.2%) in comparison with placebo (20.8%) (P<0.0001). The security profile throughout upkeep part was typically comparable between CT-P13 SC and placebo arms.

In regards to the pivotal LIBERTY-CD examine

The LIBERTY-CD is a randomized, placebo-controlled, double-blind, part III examine designed to judge the prevalence of the subcutaneous CT-P13 (CT-P13 SC) in efficacy and security throughout upkeep remedy in affected person with average to extreme energetic CD. A complete of 343 sufferers had been randomized at Week 10. At Week 54, the scientific remission charge was larger in CT-P13 SC arm than placebo arm (62.3% and 32.1% respectively, with P < 0.0001). The security profile throughout upkeep part was typically 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 fastened dose of CT-P13 SC has been authorized to be used within the European Union (EU), in adults no matter physique weight, in each present and newly added indications. The SC formulation has the potential to boost remedy choices for the usage of the infliximab drug by offering excessive consistency in drug publicity and a handy technique of administration.3.4

About Celltrion Healthcare

Celltrion Healthcare is dedicated to delivering modern and inexpensive medicines to advertise sufferers’ entry to superior therapies. Its merchandise are manufactured at state-of-the-art mammalian cell tradition amenities, designed, and constructed to adjust to the US FDA Present Good Manufacturing Observe (cGMP) and the EU GMP tips. Celltrion Healthcare endeavors to supply high-quality, cost-effective options by means of an intensive international community that spans greater than 110 completely different international locations. For extra data, please go to: https://www.celltrionhealthcare.com/en-us.

About Celltrion USA

Celltrion USA is Celltrion Healthcare’s US subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is dedicated to increasing entry to next-generation biopharmaceuticals to enhance take care of US sufferers. Celltrion at the moment has 4 biosimilars authorized by the US FDA: Remsima® (infliximab), Truxima® (rituximab), Herzuma® (trastuzumab), and Vegzelma® (bevacizumab). Celltrion USA will proceed to leverage Celltrion Healthcare’s distinctive heritage in biotechnology, provide chain excellence, and best-in-class gross sales capabilities to enhance entry to high-quality biopharmaceuticals for US sufferers.

FORWARD-LOOKING STATEMENT

Sure data set forth on this press launch incorporates statements associated to our future enterprise and monetary efficiency and future occasions or developments involving Celltrion/Celltrion Healthcare which will represent forward-looking statements, underneath pertinent securities legal guidelines.

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As well as, our representatives could make oral forward-looking statements. Such statements are based mostly on the present expectations and sure assumptions of Celltrion/Celltrion Healthcare’s administration, of which many are past its management.

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Such forward-looking statements essentially contain identified and unknown dangers and uncertainties, which can trigger precise efficiency and monetary leads to future intervals to vary materially from any projections of future efficiency or consequence expressed or implied by such forward-looking statements.

Though forward-looking statements contained on this presentation are based mostly upon what administration of Celltrion/Celltrion Healthcare believes are cheap assumptions, there will be no assurance that forward-looking statements will show to be correct, as precise outcomes and future occasions may differ materially from these anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to replace forward-looking statements if circumstances or administration’s estimates or opinions ought to change besides as required by relevant securities legal guidelines. The reader is cautioned to not place undue reliance on forward-looking statements.

References

one CT-P13 (Infliximab) Subcutaneous Administration in Sufferers With Reasonably to Severely Energetic Ulcerative Colitis (LIBERTY-UC). clinicaltrials.gov;2022. https://clinicaltrials.gov/ct2/present/NCT04205643#wrapper [Last Accessed December 2022]

2 CT-P13 (Infliximab) Subcutaneous Administration in Sufferers With Reasonably to Severely Energetic Crohn’s Illness (LIBERTY-CD). clinicaltrials.gov;2022. https://clinicaltrials.gov/ct2/present/NCT03945019 [Last Accessed December 2022]

3 Reinisch W et al. DOP62 A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year consequence from a Part I open-label randomized managed trial in sufferers with energetic Crohn’s illness, Journal of Crohn’s and Colitis, Quantity 13, Problem 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 Outcomes from Half Two of a Part I/III Randomized Managed Trial in Sufferers with Rheumatoid Arthritis. Poster (SAT0170) Introduced at EULAR 2019.

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