South Korean biotechnology company Celltrion announced on 22 September 2019 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended for approval the company’s subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).
Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.
The South Korean biotechnology company had its intravenous (IV) formulation of CT P13 (Remsima) approved in Europe in September 2013 [1]. The CHMP positive opinion of the SC formulation of CT P13 follows the successful completion of, and reporting of positive results from, phase I and III studies with the SC version of CT P13 in June 2018 [2] and August 2018 [3].
The company stated that the positive opinion ‘is based on the phase I/III stud[ies] to evaluate pharmacokinetics, efficacy and safety between CT P13 SC and the IV version in people with active RA’ [4]. Part one of this study, according to Celltrion, demonstrated that CT P13 SC showed comparable efficacy to CT P13 IV up to Week 54 with comparable Disease Activity Score 28-joint count C-reactive protein (DAS28-CRP) / DAS28-erythrocyte sedimentation rate (ESR) and American College of Rheumatology 20% response criteria (ACR20) scores (measures of disease activity) demonstrated for both routes of administration. The safety profile of CT P13 SC was also comparable to CT P13 IV [2]. The study was followed up by a phase I/III randomized controlled trial (part two) which demonstrated non-inferiority in efficacy of CT P13 SC to CT P13 IV in people with RA over 30 weeks with similar DAS28 and ACR20, ACR50, ACR70 scores and European Congress of Rheumatology (EULAR)-CRP response. The safety profile of CT P13 SC was comparable to CT P13 IV up to Week 30 [3].
The company has previously said that it is developing Remsima SC in a bid to increase its competitiveness in the TNF‑α inhibitor (autoimmune disease therapeutic agent) market through a ‘twin-track’ strategy together with the existing IV formulation of Remsima [4]. It added that the SC formulation ‘provides an alternative administration option for physicians and their patients’.
Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare, said that if the SC formulation is approved it would ‘begin a new era in the biotherapeutic class, as CT P13 SC would be the world’s first subcutaneous version of infliximab, expanding treatment options for physicians and their patients’.
The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).
The company is also carrying out a phase III study of CT P13 SC for people with inflammatory bowel disease (IBD) and is hoping to seek expanded indications following the results of this trial. Celltrion has applied for a patent for CT P13 SC in approximately 130 countries throughout the US, Europe and Asia.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. Positive results for infliximab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 27]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-infliximab-and-trastuzumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Phase III trial for subcutaneous Remsima completed [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 27]. Available from: www.gabionline.net/Biosimilars/Research/Phase-III-trial-for-subcutaneous-Remsima-completed
4. GaBI Online - Generics and Biosimilars Initiative. Safety of SC form of infliximab biosimilar CT-P13 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 27]. Available from: www.gabionline.net/Biosimilars/Research/Safety-of-SC-form-of-infliximab-biosimilar-CT-P13
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