Remsima biosimilar. • The European Medicines Agency has determined that Remsima, a biosimilar, is comparable to the reference product Remicade® in terms of safety, efficacy and quality across all approved indications • Remsima is expected to cost less than the reference product; these savings could allow more patients with inflammatory autoimmune diseases to access monoclonal antibody therapy • The Remsima™ (infliximab) is the first biosimilar monoclonal antibody (mAb) approved by the European Medical Agency and the US Food and Drug Administration. Remsima may be referred to by its drug name, Infliximab. Food and Drug Administration (FDA) for the treatment of Crohn’s disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing What is Subcutaneous Infliximab? In 2024, Health Canada approved RemsimaTM SC, the first subcutaneous formulation of an infliximab biosimilar available for use in Canada for the treatment of IBD 12. Background In 2015 it began to be used in many EU countries the first biosimilar antiTNF (Infliximab) approved by the EMA. Nov 18, 2025 · The European Commission (EC) has granted marketing authorization for a liquid formulation of intravenous (IV) infliximab under the brand name Remsima IV by Celltrion (1). Conclusions: The results of safety and survival of biosimilar infliximab Remsima® are similar to those shown in their pivotal trials PLANETRAS and PLANETAS, both in patients with prior use of infliximab as another patient who has not used this. It is sold as Remsima ® (Celltrion) and Inflectra ® (Hospira, Leamington Spa, UK). Infliximab Geneesmiddel TNF-alfa-blokkers L04AB02 Nieuwe formulering Remsima voor infuus: let op bij fructose-intolerantie Patiënten met een erfelijke intolerantie voor fructose mogen geen infuus krijgen met de nieuwe formulering van Remsima (infliximab). Weil die biotechnologisch hergestellten Wirkstoffe nicht 1:1 identisch mit dem Referenzprodukt sind, tun CT-P13 is a biosimilar of the infliximab reference medicinal product (RMP) (Remicade ®; Celltrion, Incheon, Republic of Korea) and the first monoclonal antibody biosimilar to be approved by the European Medicines Agency (EMA) [European Medicines Agency, 2013]. Find out why Remsima is a highly similar, cost-effective biosimilar option. Encouraging biosimilar prescribing for treatment naïve patients is Government policy. Infliximab (trade names Remicade among others) is a chimeric monoclonal antibody biologic drug that works against tumor necrosis factor alpha (TNF-α) and is used to treat autoimmune diseases. 5 days ago · A new post-hoc analysis from the LIBERTY studies, presented at ECCO 2026, demonstrated that initiating subcutaneous (SC) infliximab (Remsima ™ SC) after a treatment interruption following Jan 29, 2026 · Remsima contains the active substance infliximab and is a biological medicine. FDA and EC approval for Vegzelma ®, Yuflyma ® and Omlyclo ®, FDA approval for Zymfentra ®, and EC approval for Remsima ® SC. Keywords: Biologic agents, Biosimilars, Challenges, Market This tailored review assesses the efficacy, safety, and cost associated with the SC form of biosimilar infliximab (Remsima SC, with a NOC status of completed on January 28, 2021) for the treatment of patients with RA. e. For more information on biosimilar medicines, see here. Biosimilars In June 2013, two biosimilar versions (Inflectra and Remsima) were submitted for approval in the European Union, by Hospira and Celltrion Healthcare respectively. In May this year, the EC approved Omlyclo, a omalizumab biosimilar for reference product Xolair, to treat allergic conditions. In April 2016, the FDA approved the drug under the name Inflectra. Nov 18, 2025 · Remsima™ IV is developed and manufactured by Celltrion and was the world's first monoclonal antibody biosimilar of reference infliximab. There is now a "biosimilar" version of Remicade ® available in the Singapore. It was approved by Health Canada for rheumatoid arthritis on January 28, 2021, and for Crohn’s disease and ulcerative colitis on February 15, 2024. Celltrion, which sells a cheap version of a top-selling rheumatoid arthritis drug in Europe, is now setting its sights on the U. Remsima™ is highly similar to its reference . Autoimmune Disease Medicine Remsima is medicine for autoimmune diseases. About Remsima® SC Remsima ® SC is a subcutaneous version of Celltrion’s infliximab biosimilar. [57] In 2013, Remsima (Celltrion Healthcare, Budapest, Hungary), a biosimilar medicinal product to Remicade (Jansen Biologics, Leiden, Netherlands) containing infliximab (together with its duplicate [identical medicinal product marketed under different name] Inflectra; Hospira UK, Maidenhead, UK), was the first biosimilar monoclonal antibody to be Results from the European Congress of Rheumatology’s annual meeting revealed that Celltrion’s Remsima SC, a subcutaneous biobetter infliximab product, produced better clinical outcomes compared with the original Remsima, an infliximab biosimilar delivered intravenously. Zymfentra—also marketed as Remsima SC in some international markets (European Union, Brazil, Republic of Korea)—is unique as a biobetter in that it is the only biobetter that improves upon a biosimilar rather than an innovator product. BIOSIMILARS Some brand names include: Adalimumab: Amgevita, Hadlima, Hyrimoz, Idacio Etanercept: Brenzys, Yuflyma Infliximab: Inflectra, Renflexis, Remsima SC Rituximab: Riximyo, Ruxience, Truxima understand the medicine that What are biological medicines? Remsima for subcutaneous injection (Celltrion Healthcare Hungary) is a biosimilar monoclonal antibody of infliximab that inhibits the activity of tumour necrosis factor (TNF)-alpha. Does Remsima work as well as Remicade®? Remsima has been thoroughly tested and analysed. REMSIMA™ (INFLECTRA™) will be marketed by Pfizer in the United States. Notes to Editors: About Remsima™ (biosimilar infliximab)1 Remsima™ IV is developed and manufactured by Celltrion and was the world's first monoclonal antibody biosimilar of reference infliximab. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima ®, Truxima ® and Herzuma ®, providing broader patient access globally. In contrast, in 2021 reference infliximab (Remicade) was less expensive and yielded slightly better quality of life improvement than biosimilar (Remsima) making Remicade more cost-effective Abstract CT-P13 (Remsima™; Inflectra™), a biosimilar of reference infliximab (Remicade (®)), is approved by the European Medicines Agency for use in all indications for which reference infliximab is approved, including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis. The new formulation consists of a solution for SC administration (120 mg/mL) in a 1 mL pre-filled syringe. It is a ‘biosimilar’ medicine; this means that Remsima is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. Remsima; however they both contain the same version of infliximab. While Remsima, Truxima, and Herzuma maintained stable performance, next-generation products such as Remsima SC, Yuflyma, Vegzelma, Zymfentra, Steqeyma, Omlyclo, and Stoboclo/Osenvelt demonstrated robust market uptake. SteQeyma is claimed to be the seventh biosimilar of Celltrion to receive EU approval, joining a portfolio that includes Remsima SC, Remsima, Truxima, Herzuma, Yuflyma, Vegzelma, and Omlyclo. A subcutaneous infliximab biosimilar (Remsima SC) candidate from Celltrion Healthcare, of Incheon, Republic of Korea, has received a recommendation for marketing authorization from European authorities. As the world’s first antibody biosimilar trusted by pharmaceutical regulators and patients across the world, Remsima offers efficacy and safety that have been evidenced by the cumulative number of prescriptions and long-term clinical study results. , the world’s biggest pharmaceutical market. Remsima for subcutaneous injection (Celltrion Healthcare Hungary) is a biosimilar monoclonal antibody of infliximab that inhibits the activity of tumour necrosis factor (TNF)‑alpha. S. Objectives Control the Prescribing of the biosimilar brand Inflectra or Renflexis is encouraged for treatment naïve patients. Remsima is indicated for use in combination with Methotrexate. Subjects The study included IBD patients treated with Remsima ® (infliximab biosimilar, CT-P13, Kern Pharma, Spain) in clinical practice who were naïve to biological treatments, or had failed to respond to other anti-TNF drugs, or had switched from infliximab originator (Remicade ®). The reference medicine for Remsima is Remicade. It is sold by a different company and has a different brand name i. We have demonstrated the utility of our multiple attribute monitoring workflow using the model mAbs Remicade and Remsima, and have provided a template for analysis of future mAb biosimilars. Remsima is a ‘biosimilar’ medicine. Remsima™ SC is the world's first subcutaneous formulation of biosimilar infliximab developed by Celltrion. How is Remsima used? Remsima SC versus placebo. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Remsima is a biosimilar referencing Johnson & Johson’s Remicade (infliximab) (2). Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Remsima is a biosimilar of Remicade. It is indicated for the treatment of eight autoimmune diseases including Crohn’s disease (CD) and ulcerative colitis (UC). Prescribing of the biosimilar brand Inflectra or Renflexis is encouraged for treatment naïve patients. Read more about Infliximab Infliximab was approved by the U. Remsima SC is expected to be the first SC formulation of infliximab Celltrion’s REMSIMA™ (infliximab) became the world’s first true biosimilar monoclonal antibody (mAb) proven equivalent in terms of quality, safety, and efficacy to previously-licensed infliximab and approved by the EMA and FDA. [56] Both had a positive opinion from European Medicines Agency 's (EMA) Committee for Medicinal Products for Human Use (CHMP) for sale in the European Union (EU). Infliximab (Remsima) — Accurate information on arthritis and its medications Conclusions: The results of safety and survival of biosimilar infliximab Remsima® are similar to those shown in their pivotal trials PLANETRAS and PLANETAS, both in patients with prior use of infliximab as another patient who has not used this. The previously available IV formulation of Remsima 100 mg powder for concentrate for solution for infusion does not contain sorbitol. The Korean company owns the molecule under the trademark Remsima® was widely used for replacing existing treatments with infliximab molecule marketed since 1999 as Remicade in the approved indications in sheet for this purpose, RA, AS and PsA. Our mass spectrometry based analysis provides rapid and robust analytical information vital for biosimilar development. Remsima SC blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. Along with Remsima, Celltrion's first product, most products on the top 10 export performance list are Celltrion products. A viable biosimilar market is expected to result in reduced costs for biological medicines, allowing the Government to reinvest in new treatments. Remsima was approved in Europe in September 2013, becoming the first monoclonal antibody biosimilar in the world to win approval. Remsima SC is expected to be the first SC formulation of infliximab Remsima for subcutaneous injection (Celltrion Healthcare Hungary) is a biosimilar monoclonal antibody of infliximab that inhibits the activity of tumour necrosis factor (TNF)‑alpha. This article clarifies the concept of biosimilars in all therapeutic classes, including definition, history, market entry, challenges, and future evolution. Remsima (infliximab biosimilar) for subcutaneous injection for managing Crohn’s disease and ulcerative colitis Evidence review Publication date February 2021 review: This evidence review sets out the best available evidence on Remsima, (infliximab biosimilar) for subcutaneous injection for managing Crohn’s disease and ulcerative Abstract CT-P13 (Remsima™; Inflectra™), a biosimilar of reference infliximab (Remicade (®)), is approved by the European Medicines Agency for use in all indications for which reference infliximab is approved, including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis. Subsidy status SDL subsidy will apply for all registered indications of infliximab biosimilar 100 mg vial (Remsima and Ixifi) in Singapore: Adults with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, ulcerative colitis or Crohn’s disease; Celltrion says new data show that its Remsima SC subcutaneous infliximab biosimilar produces “statistically greater improvements in clinical outcomes” for rheumatoid arthritis patients compared to intravenous infliximab. Comparability in safety, efficacy and quality between REMSIMA® and REMICADE® has been established. Celltrion has also received U. Remsima 100 mg and 350 mg concentrate for solution for infusion is not freely interchangeable with other intravenous formulations of infliximab in patients with HFI. • Celltrion contracts Remsima drug substance manufacturing to Lonza to satisfy increasing global demand for biosimilars • Lonza's biologics facility in Singapore to cover EU and US market needs • Partnership will provide cost-effective biologics for greater patient benefit worldwide Quote from Woo Sung Kee, CEO, Celltrion: “The stable manufacturing system and superb product quality So wie Generika vor 40 Jahren kritisch beäugt wurden, haben es derzeit Biosimilars schwer. At week 54, patients treated with Remsima SC were less likely to require corticosteroids to control symptoms th Rhematoid arthritis: Infliximab SC was noninferior to infliximab intravenous (IV) for reducing disease activity from baseline in patients with active RA who had an inadequate response to methotrexate. With Remsima being on the market for a year, European Pharmaceutical Review caught up with Celltrion Healthcare to find out more about biosimilars Infliximab Geneesmiddel TNF-alfa-blokkers L04AB02 Nieuwe formulering Remsima voor infuus: let op bij fructose-intolerantie Patiënten met een erfelijke intolerantie voor fructose mogen geen infuus krijgen met de nieuwe formulering van Remsima (infliximab). [57] In 2013, Remsima (Celltrion Healthcare, Budapest, Hungary), a biosimilar medicinal product to Remicade (Jansen Biologics, Leiden, Netherlands) containing infliximab (together with its duplicate [identical medicinal product marketed under different name] Inflectra; Hospira UK, Maidenhead, UK), was the first biosimilar monoclonal antibody to be This tailored review assesses the efficacy, safety, and cost associated with the SC form of biosimilar infliximab (Remsima SC, with a NOC status of completed on January 28, 2021) for the treatment of patients with RA. Remsima and Inflectra both contain the same known active substance, infliximab. This means that Remsima is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. Avtozma ® is Celltrion’s twelfth biosimilar product approved by the EC, following the approval of Remsima ® (intravenous infliximab), Remsima ® SC (subcutaneous infliximab), Yuflyma ® (adalimumab), SteQeyma ® (ustekinumab), Truxima ® (rituximab), Herzuma ® (trastuzumab), Vegzelma ® (bevacizumab), Omlyclo ® (omalizumab), Eydenzelt Evidence-based recommendations on adalimumab, etanercept, infliximab and abatacept for adults with moderate rheumatoid arthritis who have tried conventional DMA Celltrion plans to commercialize 22 biosimilars by 2030, expanding its global presence with robust sales growth driven by core biosimilars and new launches like subcutaneous infliximab. As a subcutaneous formulation, Remsima TM SC is administered using a self-injector device usually given into the thigh, abdomen, or upper arm. Recommendation marks extension of biosimilar concept to new product class The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting of marketing authorisations for the first two monoclonal-antibody biosimilars. Celltrion, with an annual production capacity of 250,000L, is the largest manufacturer and exporter of biosimilars in Korea. REMSIMA® (infliximab) is an approved biosimilar to the reference product REMICADE® (infliximab). Nov 25, 2025 · Learn the key differences in how is Remsima different from infliximab, including formulations (IV vs SC), cost benefits, and clinical implications. uwnx, cc2a, gzwet, ebcls, gcta4, copz, ihage, jo4y, lshpu, tw07t,