Infliximab (infliximab)
Infliximab is a tnf blocker — chimeric human-murine igg1 monoclonal antibody against tnf-alpha (bdmard, intravenous infusion) from Janssen Biotech / Johnson & Johnson (originally Centocor); initial U.S. approval 1998, marketed originally as Remicade. This monograph covers approved indications, mechanism, dosing, side effects, the generic manufacturer landscape and verified list prices.
Overview
Infliximab is a chimeric human-murine IgG1 monoclonal antibody against TNF-alpha, first approved in the United States in 1998 as Remicade (Janssen Biotech, originally Centocor). It was one of the first biologics to transform the treatment of inflammatory bowel disease, and unlike adalimumab it is given as an intravenous infusion over at least two hours, usually at 5 mg/kg on a 0, 2 and 6 week schedule and then every eight weeks. Infliximab binds both soluble and transmembrane TNF-alpha, inhibiting its binding to the p55 and p75 receptors, but it does not neutralise lymphotoxin-alpha (TNF-beta). It is approved for Crohn's disease and ulcerative colitis in adults and children from 6 years of age, rheumatoid arthritis in combination with methotrexate, ankylosing spondylitis, psoriatic arthritis and severe plaque psoriasis.
The boxed warning covers serious infections and malignancy, with the same tuberculosis, invasive fungal infection, hepatitis B reactivation and lymphoma concerns that apply to other TNF blockers. Infliximab has an additional problem of its own: anti-drug antibodies. Because the molecule contains murine sequence, patients can develop antibodies that increase clearance and are associated with loss of response and infusion reactions. Dose escalation to 10 mg/kg or shorter intervals, guided by drug-level and anti-drug-antibody testing, is commonly used to manage this. Infusion reactions, delayed hypersensitivity, cytopenias, drug-induced lupus, hepatotoxicity, demyelinating disease and new or worsening heart failure are also reported.
Infliximab is a biologic with no generic and no ANDA. Its follow-on products are biosimilars: Inflectra, Renflexis and Avsola are FDA-approved to Remicade, and CT-P13 (Remsima) was one of the earliest monoclonal antibody biosimilars anywhere. India launched Infimab in 2014 as its first similar biologic, and in Bangladesh MedEx lists Remicade at BDT 44,400 and Remsima at BDT 34,900 per 100 mg vial.
Infliximab price list — Bangladesh
Every DGDA-registered brand of this molecule with its list unit price, including the originator for comparison. Bangladesh is the most transparent reference market for on-patent generics.
| Brand | Manufacturer | Strength | Unit price | ≈ USD | Pack |
|---|---|---|---|---|---|
| Remsima | ZAS Corporation (Mfg. by: Celltrion Pharma Inc, Korea) | 100 mg/20 ml Intravitreal Injection | — | — | — |
| Remicade Originator | UniMed UniHealth Pharmaceuticals Ltd. (Mfg. by: Cilag AG Switzerland) | 100 mg/20 ml Intravitreal Injection | — | — | — |
Source: MedEx Bangladesh drug registry (list prices of DGDA-registered brands). Unit prices move with pack size, pharmacy and exchange rate — reference only. Original registry page
How it works
Infliximab is a lab-made antibody given as an intravenous infusion that sticks to TNF-alpha, the messenger molecule that drives inflammation. Neutralising TNF-alpha calms disease activity in the gut, joints, spine and skin.
Infliximab is a chimeric human-murine IgG1 monoclonal antibody that binds with high affinity to both the soluble and transmembrane forms of human TNF-alpha, inhibiting binding of TNF-alpha to its p55 and p75 receptors. It does not neutralise lymphotoxin-alpha (TNF-beta). It reduces induction of pro-inflammatory cytokines such as IL-1 and IL-6, decreases endothelial adhesion molecule expression and leukocyte migration, and can lyse cells expressing transmembrane TNF-alpha in vitro in the presence of complement or effector cells. Formation of anti-infliximab antibodies increases clearance and is associated with loss of response and infusion reactions.
Approved indications
- Crohn's disease: reducing signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active disease who had an inadequate response to conventional therapy; reducing draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure
- Pediatric Crohn's disease: patients 6 years of age and older with moderately to severely active disease with inadequate response to conventional therapy
- Ulcerative colitis: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adults with moderately to severely active disease with inadequate response to conventional therapy
- Pediatric ulcerative colitis: patients 6 years of age and older
- Rheumatoid arthritis (in combination with methotrexate): reducing signs and symptoms, inhibiting progression of structural damage and improving physical function in adults with moderately to severely active disease
- Ankylosing spondylitis: reducing signs and symptoms in adults with active disease
- Psoriatic arthritis: reducing signs and symptoms of active arthritis, inhibiting progression of structural damage and improving physical function in adults
- Plaque psoriasis: treatment of adults with chronic severe (extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate
Dosage & administration
Intravenous infusion over at least 2 hours with an in-line filter. Crohn's disease and ulcerative colitis (adults and pediatric patients 6 years and older): 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; some adults who lose response may benefit from 10 mg/kg every 8 weeks. Rheumatoid arthritis (with methotrexate): 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; some patients may increase to 10 mg/kg every 8 weeks or dose as often as every 4 weeks. Ankylosing spondylitis: 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks. Psoriatic arthritis and plaque psoriasis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Supplied as 100 mg lyophilized powder per single-dose vial for reconstitution and dilution.
Dose adjustment
No specific renal- or hepatic-impairment dose adjustment is provided in the FDA label. Contraindicated at doses greater than 5 mg/kg in patients with moderate or severe heart failure, and contraindicated in patients with a previous severe hypersensitivity reaction to infliximab, its inactive ingredients or any murine proteins. Doses may be escalated (e.g. 10 mg/kg or shorter intervals) in adult IBD or RA patients who lose response; in practice, infliximab trough levels and anti-drug antibodies are used to guide this.
Side effects
Autoantibody formation and drug-induced lupus · Demyelinating disease · Psoriasis and other skin reactions
- Infusion reactions (fever, chills, urticaria, dyspnea) and delayed hypersensitivity reactions
- Serious infections including tuberculosis, bacterial sepsis and invasive fungal infections such as histoplasmosis
- Reactivation of hepatitis B
- Lymphoma and other malignancies including hepatosplenic T-cell lymphoma (HSTCL)
- New-onset or worsening heart failure
- Cytopenias (leukopenia, neutropenia, thrombocytopenia, anemia)
- Hepatotoxicity and jaundice
- In pediatric patients: anemia, leukopenia, neutropenia, flushing, viral and bacterial infections, bone fracture
SERIOUS INFECTIONS and MALIGNANCY. Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue infliximab if a patient develops a serious infection. Perform a test for latent TB; if positive, start treatment for TB prior to starting infliximab, and monitor all patients for active TB during treatment even if the initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported with TNF blockers; almost all patients had received azathioprine or 6-mercaptopurine concomitantly or prior to diagnosis, and the majority of infliximab cases were in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males.
Monitoring
- Test for latent tuberculosis before starting and monitor for active TB during treatment
- Monitor for serious infections, including invasive fungal infections, during and after treatment
- Screen for hepatitis B virus and monitor for HBV reactivation
- Monitor for infusion reactions and delayed hypersensitivity, and consider anti-drug antibody testing on loss of response
- Monitor for new-onset or worsening heart failure
- Monitor blood counts for cytopenias
- Monitor liver enzymes for hepatotoxicity
- Monitor for neurologic symptoms suggestive of demyelinating disease
- Evaluate for malignancy during and after therapy
Generic and biosimilar landscape
Infliximab is a biologic: there is no generic and no ANDA. Follow-on products are biosimilars approved through FDA 351(k) or the EMA and other national biosimilar pathways, requiring comparability data on safety, purity and potency rather than plasma bioequivalence. FDA-approved infliximab biosimilars to Remicade include Inflectra, Renflexis and Avsola; Ixifi was approved but not launched in the US. In India and other Asian markets these products are regulated as 'similar biologics' or biosimilars under national guidelines. Biosimilars are not automatically interchangeable — substitution decisions remain with the prescriber unless the regulator grants interchangeability. The subcutaneous formulation (Zymfentra / Remsima SC) is a distinct product with different pharmacokinetics and is not a generic substitute for IV infliximab.
Who makes it
| Manufacturer | Country | Brand | Strength | Notes |
|---|---|---|---|---|
| Ranbaxy Laboratorieswith Epirus Biopharmaceuticals | India | Infimab (BOW015) | 100 mg vial for IV infusion | India's first infliximab biosimilar, launched 1 December 2014; the first Remicade 'similar biologic' in India |
| Reliance Life Sciences | India | InflixiRel | 100 mg vial | Indian infliximab biosimilar; Reliance acquired global rights to the Epirus infliximab biosimilar after Epirus' bankruptcy; trade listings show around INR 10,500 per 100 mg vial |
| Celltrion | South Korea / Bangladesh | Remsima (CT-P13) | 100 mg/20 mL vial (also subcutaneous Remsima SC in some markets) | World's first infliximab biosimilar; approved in Thailand in 2015; MedEx-listed in Bangladesh at BDT 34,900 per 100 mg vial; registered and subsidised for all registered indication |
| Janssen / Cilag AG | Switzerland (marketed in Bangladesh by UniMed UniHealth) | Remicade | 100 mg/20 mL vial | Originator product, not a biosimilar; MedEx-listed in Bangladesh at BDT 44,400 per 100 mg vial |
| Pfizer | United States | Inflectra (infliximab-dyyb) and Ixifi (infliximab-qbtx) | 100 mg vial | US FDA-approved infliximab biosimilars to Remicade; Ixifi was approved but not launched in the US; both appear in Singapore's registered infliximab biosimilar guidance |
Availability in Southeast Asia
| Country | Status | Notes |
|---|---|---|
| Thailand | Infliximab biosimilar CT-P13 approved in Thailand since 2015 | Safety and effectiveness of intravenous CT-P13 studied in Thai rheumatic disease patients (PubMed 37589164); Celltrion biosimilars also contracted into SE Asian supply deals |
| Singapore | Registered infliximab biosimilars (Remsima, Ixifi) with subsidy guidance covering all registered indications | ACE-HTA Singapore technology guidance for intravenous infliximab biosimilars 100 mg vial |
| Malaysia | Infliximab biosimilar received marketing approval in Malaysia | Kexing Biopharm announced marketing approval for its licensed-in infliximab in Malaysia (December 2025) |
| Bangladesh | Remicade (originator) and Remsima (biosimilar) both listed with prices | MedEx price list: Remicade BDT 44,400 and Remsima BDT 34,900 per 100 mg vial |
| India | Multiple infliximab biosimilars marketed since 2014 | Infimab (Ranbaxy/Sun Pharma, first Indian biosimilar) and InflixiRel (Reliance Life Sciences); regional comparator rather than SEA |
| Vietnam | Not confirmed by retrieved sources | |
| Indonesia | Not confirmed by retrieved sources | |
| Philippines | Not confirmed by retrieved sources |
Price by country
Reference prices by market
| Market | Product | Listed price | Source |
|---|---|---|---|
| Bangladesh | Remicade 100 mg/20 mL IV vial (originator) | BDT 44,400 per 100 mg vial | medex.com.bd |
| Bangladesh | Remsima 100 mg/20 mL IV vial (Celltrion biosimilar) | BDT 34,900 per 100 mg vial | medex.com.bd |
| India | InflixiRel (Reliance Life Sciences) infliximab 100 mg vial | INR 10,500 per 100 mg vial (trade listing) | indiamart.com |
Frequently asked questions
Is infliximab a biosimilar or a generic?
Infliximab is a biologic: there is no generic and no ANDA. Follow-on products are biosimilars approved through FDA 351(k) or the EMA and other national biosimilar pathways, requiring comparability data on safety, purity and potency rather than plasma bioequivalence. FDA-approved infliximab biosimilars to Remicade include Inflectra, Renflexis and Avsola; Ixifi was approved but not launched in the US. In India and other Asian markets these products are regulated as 'similar biologics' or biosimilars under national guidelines. Biosimilars are not automatically interchangeable — substitution decisions remain with the prescriber unless the regulator grants interchangeability. The subcutaneous formulation (Zymfentra / Remsima SC) is a distinct product with different pharmacokinetics and is not a generic substitute for IV infliximab. Manufacturers supplying infliximab generic versions include Celltrion, Janssen / Cilag AG, Pfizer, Ranbaxy Laboratories, Reliance Life Sciences. Brands registered in Bangladesh include Remicade, Remsima.
What is the difference between Remicade, Remsima and Infimab?
Infliximab (TNF blocker — chimeric human-murine IgG1 monoclonal antibody against TNF-alpha (bDMARD, intravenous infusion), originally Remicade (类克) by Janssen Biotech / Johnson & Johnson (originally Centocor); initial U.S. approval 1998) Infliximab is a lab-made antibody given as an intravenous infusion that sticks to TNF-alpha, the messenger molecule that drives inflammation. Neutralising TNF-alpha calms disease activity in the gut, joints, spine and skin. Intravenous infusion over at least 2 hours with an in-line filter. Crohn's disease and ulcerative colitis (adults and pediatric patients 6 years and older): 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; some adults who lose response may benefit from 10 mg/kg every 8 weeks. Rheumatoid arthritis (with methotrexate): 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; some patients may increase to 10
What is the dose and schedule of infliximab for Crohn's disease?
Standard dosing for infliximab: Intravenous infusion over at least 2 hours with an in-line filter. Crohn's disease and ulcerative colitis (adults and pediatric patients 6 years and older): 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; some adults who lose response may benefit from 10 mg/kg every 8 weeks. Rheumatoid arthritis (with methotrexate): 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; some patients may increase to 10 mg/kg every 8 weeks or dose as often as every 4 weeks. Ankylosing spondylitis: 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks. Psoriatic arthritis and plaque psoriasis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Supplied as 100 mg lyophilized powder per single-dose vial for reconstitution and dilution. Dose adjustments: No specific renal- or hepatic-impairment dose adjustment is provided in the FDA label. Contraindicated at doses greater than 5 mg/kg in patients with moderate or severe heart failure, and contraindicated in patients with a previous severe hypersensitivity reaction to infliximab, its inactive ingredients or any murine proteins. Doses may be escalated (e.g. 10 mg/kg or shorter intervals) in adult IBD or RA patients who lose response; in practice, infliximab trough levels and anti-drug antibodies are used to guide this.
Why does infliximab have to be given as an intravenous infusion?
Infliximab (TNF blocker — chimeric human-murine IgG1 monoclonal antibody against TNF-alpha (bDMARD, intravenous infusion), originally Remicade (类克) by Janssen Biotech / Johnson & Johnson (originally Centocor); initial U.S. approval 1998) Infliximab is a lab-made antibody given as an intravenous infusion that sticks to TNF-alpha, the messenger molecule that drives inflammation. Neutralising TNF-alpha calms disease activity in the gut, joints, spine and skin. Intravenous infusion over at least 2 hours with an in-line filter. Crohn's disease and ulcerative colitis (adults and pediatric patients 6 years and older): 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; some adults who lose response may benefit from 10 mg/kg every 8 weeks. Rheumatoid arthritis (with methotrexate): 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; some patients may increase to 10
What is the boxed warning on Remicade?
Infliximab (TNF blocker — chimeric human-murine IgG1 monoclonal antibody against TNF-alpha (bDMARD, intravenous infusion), originally Remicade (类克) by Janssen Biotech / Johnson & Johnson (originally Centocor); initial U.S. approval 1998) Infliximab is a lab-made antibody given as an intravenous infusion that sticks to TNF-alpha, the messenger molecule that drives inflammation. Neutralising TNF-alpha calms disease activity in the gut, joints, spine and skin. Intravenous infusion over at least 2 hours with an in-line filter. Crohn's disease and ulcerative colitis (adults and pediatric patients 6 years and older): 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; some adults who lose response may benefit from 10 mg/kg every 8 weeks. Rheumatoid arthritis (with methotrexate): 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; some patients may increase to 10
How is infliximab stored and can it be kept at room temperature?
Storage: Store unopened Remicade vials in a refrigerator at 2°C to 8°C (36°F to 46°F). If needed, unopened vials may be stored at room temperature up to a maximum of 30°C (86°F) for a single period of up to 6 months but not exceeding the original expiry date; the new expiration date must be written on the carton. Once removed from the refrigerator, Remicade cannot be returned to the refrigerator. The reconstituted and diluted product has a separate, shorter storage window per section 2.11 of the label. Keep the product in its original packaging and check the expiry date printed on the pack.
What is the half-life of infliximab?
Elimination half-life: Median terminal half-life of 7.7 to 9.5 days (from pharmacokinetic results for single doses of 3 mg/kg to 10 mg/kg in RA, 5 mg/kg in Crohn's disease and 3 mg/kg to 5 mg/kg in psoriasis). No systemic accumulation occurs with continued repeated treatment, although clearance increases in the presence of anti-infliximab antibodies. Pharmacokinetics are similar in pediatric (6-17 years) and adult patients with Crohn's disease or ulcerative colitis.. Dosing intervals are designed around this, which is why most regimens are once or twice daily.
Can infliximab cause infusion reactions?
The most frequently reported side effects of infliximab are infusion reactions (fever, chills, urticaria, dyspnea) and delayed hypersensitivity reactions, serious infections including tuberculosis, bacterial sepsis and invasive fungal infections such as histoplasmosis, reactivation of hepatitis b, lymphoma and other malignancies including hepatosplenic t-cell lymphoma (hstcl), autoantibody formation and drug-induced lupus, new-onset or worsening heart failure, cytopenias (leukopenia, neutropenia, thrombocytopenia, anemia). Serious but less common reactions include serious infections including tuberculosis, bacterial sepsis and invasive fungal infections such as histoplasmosis, reactivation of hepatitis b, lymphoma and other malignancies including hepatosplenic t-cell lymphoma (hstcl), new-onset or worsening heart failure. Routine monitoring: Test for latent tuberculosis before starting and monitor for active TB during treatment; Monitor for serious infections, including invasive fungal infections, during and after treatment; Screen for hepatitis B virus and monitor for HBV reactivation. Report any new or worsening symptom to your treating physician — most adverse effects are managed by dose reduction rather than stopping treatment.
How much does an infliximab vial cost in Bangladesh and India?
Bangladesh unit prices for infliximab are not published per unit; the registry lists pack prices only. Prices move with pack size, pharmacy and the exchange rate — confirm current stock and price with a licensed importer before ordering.
Is infliximab safe to use in heart failure?
Infliximab (TNF blocker — chimeric human-murine IgG1 monoclonal antibody against TNF-alpha (bDMARD, intravenous infusion), originally Remicade (类克) by Janssen Biotech / Johnson & Johnson (originally Centocor); initial U.S. approval 1998) Infliximab is a lab-made antibody given as an intravenous infusion that sticks to TNF-alpha, the messenger molecule that drives inflammation. Neutralising TNF-alpha calms disease activity in the gut, joints, spine and skin. Intravenous infusion over at least 2 hours with an in-line filter. Crohn's disease and ulcerative colitis (adults and pediatric patients 6 years and older): 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; some adults who lose response may benefit from 10 mg/kg every 8 weeks. Rheumatoid arthritis (with methotrexate): 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks; some patients may increase to 10
Sources
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/103772s5412lbl.pdf
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103772s5401lbl.pdf
- https://medex.com.bd/generics/1552/infliximab/brand-names
- https://medex.com.bd/generics/1552/infliximab
- https://www.ema.europa.eu/en/documents/product-information/remicade-epar-product-information_en.pdf
- https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/REMICADE-pi.pdf
- https://gabionline.net/es/biosimilares/novedades/First-infliximab-similar-biologic-launched-in-India
- https://www.rttnews.com/2423602/ranbaxy-launches-first-biosimilar-of-infliximab-drug-in-india.aspx
- https://rellife.com/web/lifesciences/infimab-infliximab
- https://pubmed.ncbi.nlm.nih.gov/37589164
- https://www.ace-hta.gov.sg/healthcare-professionals/ace-technology-guidance/drug-guidance/infliximab-biosimilar-for-treating-inflammatory-condition
- https://www.kexingbiopharm.com/news-and-information/1251.html
- https://www.indiamart.com/proddetail/infixirel-infliximab-100-mg-by-reliance-2858743749191.html
- https://www.goodrx.com/remicade/biosimilar-list
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