INCHEON, South Korea--(BUSINESS WIRE)--Celltrion Healthcare today announced that the European Commission (EC) has granted marketing authorisation for Remsima (infliximab, CT-P13) subcutaneous (SC) formulation for the treatment of adult patients with ankylosing spondylitis, Crohns disease, ulcerative colitis, psoriatic arthritis and psoriasis.1
The approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June and is based on data from a pivotal study comparing the pharmacokinetics, efficacy and safety of the SC and intravenous (IV) formulations of Remsima in people with active Crohns disease and ulcerative colitis, throughout a 1-year treatment period.2,3 Based on the results of the pivotal study, a 120 mg fixed dose of Remsima SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications.
Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany said: The subcutaneous formulation of Remsima (Remsima SC) has been shown to have very high efficacy, and favourable data, which are fully comparable to the efficacy and safety profile of the IV formulation. Todays approval marks an important progress for the gastroenterology community as it means that treatment can now be administered in significantly less time, thereby providing patients more flexibility and control over how they receive their treatment.
We are pleased to announce this important regulatory milestone earlier than we expected, with the European Commission prioritising review of this important new administration option. We will accelerate the launch process on a country-by-country basis in order to expand treatment options for patients with chronic inflammatory diseases such as inflammatory bowel disease and ankylosing spondylitis, said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. We will do our best to make Remsima SC available as early as possible and hope this medication will contribute to minimising the risks involved with administering medical treatments during the COVID-19 pandemic.
Celltrion anticipates receiving approval of Remsima SC in 97 countries, including 31 countries in Europe.
-- ENDS --
Notes to Editors:
About Remsima (CT-P13) intravenous (IV) formulation1Remsima IV is usually given as 3 mg per kg/body weight in rheumatoid arthritis (RA) and as 5 mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.
About Remsima CT-P13 subcutaneous (SC) formulation4,5A 120 mg fixed dose of Remsima SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications for the IV formulation. Remsima SC has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.
About CT-P13 (biosimilar infliximab)CT-P13 is developed and manufactured by Celltrion, Inc. and was the worlds first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including RA and IBD. It was approved by the EC under the trade name Remsima in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra. CT-P13 is approved in more than 94 countries (as of July 2020) including the US, Canada, Japan and throughout Europe.
About Celltrion HealthcareCelltrion 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 cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours 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
Forward-looking statement disclaimerCertain information set forth in this press release contains statements related to our future business and financial performance, and future events or developments involving Celltrion Healthcare, that may constitute forward-looking statements, under pertinent securities laws.
These statements may be identified by words such as will, has potential to, brings, if approved, would, could, opportunity, hope, is considering the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Healthcare's management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand managements beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this presentation are based upon what management of Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or managements estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
References
1 European Medicines Agency Summary of Product Characteristics (SmPC). Remsima.
2 Reinisch W, et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase 1 open-label randomised controlled trial in patients with active Crohns disease. European Crohns and Colitis Organisation 2019. Abstract no: A-1103.
3 Ben-Horin S, et al. A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohns disease and ulcerative colitis. Oral presentation (OP24). Presented at ECCO 2020.
4 Yoo DH, Jaworski J, Matyska-Piekarska E et al. A Novel Formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: One-year results from part one of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (FRI0128). Presented at EULAR 2019.
5 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.
More here:
- Why Jews With Psoriasis Might Think Twice About Seeking Treatment in Jordan - December 20th, 2013 [December 20th, 2013]
- Skin conditions leave emotional scars - December 20th, 2013 [December 20th, 2013]
- Psoriasis Free Forever Review | How This Program Helps People Treat The Root Causes Of Their Psoriasis Symptoms ... - December 20th, 2013 [December 20th, 2013]
- Psoriasis | University of Maryland Medical Center - December 20th, 2013 [December 20th, 2013]
- Psoriasis Treatment, Symptoms, Pictures, Types, Prognosis ... - December 20th, 2013 [December 20th, 2013]
- Psoriasis - National Library of Medicine - PubMed Health - December 20th, 2013 [December 20th, 2013]
- Psoriasis: MedlinePlus - U.S. National Library of Medicine - December 20th, 2013 [December 20th, 2013]
- Psoriasis - Wikipedia, the free encyclopedia - December 20th, 2013 [December 20th, 2013]
- Psoriasis Symptoms, Treatment, Causes, Medication Information ... - December 21st, 2013 [December 21st, 2013]
- Psoriasis Free For Life Review - Watch This Before You Buy - Video - December 21st, 2013 [December 21st, 2013]
- Natural Psoriasis Relief in Seattle, Washington - Video - December 21st, 2013 [December 21st, 2013]
- PSORIASIS VULGARIS - Video - December 21st, 2013 [December 21st, 2013]
- Top 5 Powerful Home Remedies For Psoriasis - Video - December 21st, 2013 [December 21st, 2013]
- Psoriasis feedback after hijama - Video - December 21st, 2013 [December 21st, 2013]
- 9 Home Remedies For Scalp Psoriasis - Video - December 22nd, 2013 [December 22nd, 2013]
- Manga - Psoriasis - Video - December 22nd, 2013 [December 22nd, 2013]
- How to treat psoriasis | In Good Shape - Interview - Video - December 22nd, 2013 [December 22nd, 2013]
- Best Scalp Psoriasis Treatment - Video - December 22nd, 2013 [December 22nd, 2013]
- Sandoz begins Phase III clinical trial for biosimilar adalimumab - December 23rd, 2013 [December 23rd, 2013]
- Psoriasis - Wikipedia, la enciclopedia libre - December 23rd, 2013 [December 23rd, 2013]
- What Is Psoriasis? - December 23rd, 2013 [December 23rd, 2013]
- Psoriasis Treatment Medical Course - Video - December 23rd, 2013 [December 23rd, 2013]
- Healing Psoriasis Hypnosis Session - Video - December 23rd, 2013 [December 23rd, 2013]
- Natural Farm cure for Skin Problems like Psoriasis - Video - December 26th, 2013 [December 26th, 2013]
- Psoriasis - 100% Natural Treatment Shivax® - December 27th, 2013 [December 27th, 2013]
- Psoriasis Symptoms, Causes, Treatment - What is psoriasis ... - December 28th, 2013 [December 28th, 2013]
- 79 PSORIASIS SYMPTOMS HOMEOPATHY TREATMENT K N SRIDHAR P3 - Video - December 28th, 2013 [December 28th, 2013]
- 79 PSORIASIS SYMPTOMS HOMEOPATHY TREATMENT K N SRIDHAR P2 - Video - December 28th, 2013 [December 28th, 2013]
- 79 PSORIASIS SYMPTOMS HOMEOPATHY TREATMENT K N SRIDHAR P1 - Video - December 28th, 2013 [December 28th, 2013]
- Can Acupuncture treat psoriasis and other scalp disorders? - Video - December 28th, 2013 [December 28th, 2013]
- Psoriasis - Wikipédia - December 31st, 2013 [December 31st, 2013]
- Psoriatic nails - Wikipedia, the free encyclopedia - December 31st, 2013 [December 31st, 2013]
- How to Cure Psoriasis - Psoriasis Symptoms, Treatment, Causes, Medication Information - Video - December 31st, 2013 [December 31st, 2013]
- Psoriasis Chronicles - Dealing with Depression, Anxiety and Anger - Video - January 2nd, 2014 [January 2nd, 2014]
- How to Prevent Psoriasis Flare-Ups - January 4th, 2014 [January 4th, 2014]
- Psoriasis Treatment | Health Plus | Studio N - Video - January 4th, 2014 [January 4th, 2014]
- Ayurvedic Remedy for Psoriasis - By Panditha Elchuri - Video - January 4th, 2014 [January 4th, 2014]
- Silica Gel For Psoriasis / Neurodermatitis - Video - January 4th, 2014 [January 4th, 2014]
- comment traiter son psoriasis détail oubliés - Video - January 4th, 2014 [January 4th, 2014]
- Psoriasis tends to relapse after stopping Methotrexate, shown in a case at Life Force - Video - January 4th, 2014 [January 4th, 2014]
- hiking nevada Health and Wellness Enthusiast Dawn Talks About Managing Plaque Psoriasis hiking watch - Video - January 5th, 2014 [January 5th, 2014]
- Guttate psoriasis - Wikipedia, the free encyclopedia - January 7th, 2014 [January 7th, 2014]
- Biofeedback May Help Control Stress-Related Diseases - January 8th, 2014 [January 8th, 2014]
- Psoriasis can be managed with proper treatment - January 10th, 2014 [January 10th, 2014]
- CNN anchor: How I fight psoriasis - January 10th, 2014 [January 10th, 2014]
- Psoriasis - My Home Remedies - January 10th, 2014 [January 10th, 2014]
- Psoriasis: MedlinePlus en español - January 10th, 2014 [January 10th, 2014]
- Psoriatic arthritis - Wikipedia, the free encyclopedia - January 10th, 2014 [January 10th, 2014]
- CNN anchor Zain Verjee: How I fight psoriasis - January 11th, 2014 [January 11th, 2014]
- Testimonio psoriasis - Video - January 14th, 2014 [January 14th, 2014]
- Heroin addict with severe Psoriasis - Video - January 15th, 2014 [January 15th, 2014]
- biospray for Psoriasis - Video - January 15th, 2014 [January 15th, 2014]
- Psoriasis - Psoriasis Free For Life - Video - January 15th, 2014 [January 15th, 2014]
- 8 Cure For Scalp Psoriasis - Video - January 15th, 2014 [January 15th, 2014]
- Learn about plaque psoriasis, guttate psoriasis, inverse ... - January 16th, 2014 [January 16th, 2014]
- Psoriasis - Symptoms, Triggers, and Causes of Psoriasis on WebMD - January 16th, 2014 [January 16th, 2014]
- Psoriasis Causes, Symptoms, Treatments, Home Remedies - January 16th, 2014 [January 16th, 2014]
- Psoriasis Treatment - Dermasis Psoriasis Cream - My Honest Review - Video - January 16th, 2014 [January 16th, 2014]
- TV Commercial Psoriasis Speaks Couple Looking At Rings In Jewelery Store Emotional - Video - January 16th, 2014 [January 16th, 2014]
- TV Commercial Humira Psoriasis Medication Salon Clearer Skin is Possible - Video - January 16th, 2014 [January 16th, 2014]
- Psoriasis Symptoms, Causes and Treatment Pictures Slideshow - Video - January 16th, 2014 [January 16th, 2014]
- Psoriasis - Medscape Reference - January 19th, 2014 [January 19th, 2014]
- 5 Home Remedies For Scalp Psoriasis - Video - January 19th, 2014 [January 19th, 2014]
- Ikonsulta Mo: Medical Advise on Psoriasis - Video - January 19th, 2014 [January 19th, 2014]
- Patient Recruitment: Television Campaign for Severe Psoriasis - Video - January 23rd, 2014 [January 23rd, 2014]
- Patient Recruitment: Television Campaign for resistant, summertime Mild to Moderate Psoriasis - Video - January 23rd, 2014 [January 23rd, 2014]
- Dr stephen ferguson ND PhD chronic fatigue psoriasis cured - Video - January 23rd, 2014 [January 23rd, 2014]
- Noir Naturals Age of Innocence (Unscented) Goat's Milk Lotion for Psoriasis Relief - Video - January 23rd, 2014 [January 23rd, 2014]
- New biologic drugs offer relief for psoriasis sufferers - January 24th, 2014 [January 24th, 2014]
- Psoriasis traitement appliquer le lait pour le corps ISO UREA MD Vidéo La Roche Posay INFO PSO - Video - January 24th, 2014 [January 24th, 2014]
- Psoriasis - Video - January 24th, 2014 [January 24th, 2014]
- Coping with psoriasis - Video - January 26th, 2014 [January 26th, 2014]
- Exfoliative Dermatitis/Psoriasis Vulgaris with Psoriatic Arthritis with English Subtitles - Video - January 26th, 2014 [January 26th, 2014]
- Psoriasis skin care routine 2014 - Video - January 27th, 2014 [January 27th, 2014]
- How to treat psoriasis effectively - By Franziska Ringpfeil, Board Certified Dermatologist - Video - January 28th, 2014 [January 28th, 2014]
- My Psoriasis 411: Apple Cider Vinegar Tutorial for Scalp Treatment - Video - January 29th, 2014 [January 29th, 2014]
- 12 Best and Worst Foods for Psoriasis - January 31st, 2014 [January 31st, 2014]
- Psocial Psoriasis en radio Tagoror - Video - January 31st, 2014 [January 31st, 2014]
- Psocial Psoriasis en Canarias Hoy - Video - January 31st, 2014 [January 31st, 2014]
- Psoriasis Natural Treatment that Workswww savevid com - Video - January 31st, 2014 [January 31st, 2014]