Remsima (Infliximab)
TNF Inhibitor — Biosimilar Monoclonal Antibody for Autoimmune & Inflammatory Conditions
Remsima is a biosimilar medicine containing infliximab, a monoclonal antibody that blocks tumor necrosis factor alpha (TNF-alpha). It is used to treat several chronic inflammatory and autoimmune conditions including rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, and ankylosing spondylitis. Remsima is available as an intravenous infusion and as a subcutaneous injection pen for self-administration at home.
Quick Facts
Key Takeaways
- Remsima (infliximab) is a biosimilar TNF inhibitor approved for rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, and ankylosing spondylitis.
- Screening for tuberculosis (TB) and hepatitis B is mandatory before starting treatment, as infliximab can reactivate latent infections.
- Treatment typically starts with intravenous infusions and can transition to self-administered subcutaneous injections (120 mg every 2 weeks).
- Live vaccines must be avoided during treatment and for infants exposed in utero for at least 12 months after birth.
- Common side effects include infections, injection reactions, headache, and abdominal pain; serious risks include severe infections, lymphoma, and heart failure.
What Is Remsima and What Is It Used For?
Remsima belongs to a class of medicines known as TNF inhibitors (tumor necrosis factor inhibitors). It contains the active substance infliximab, which is a chimeric monoclonal antibody—a type of protein engineered to specifically recognize and bind to a target in the body called TNF-alpha (tumor necrosis factor alpha). TNF-alpha is a naturally occurring cytokine that plays a central role in the inflammatory cascade. In healthy individuals, TNF-alpha helps fight infections and heal injuries. However, in autoimmune and chronic inflammatory diseases, the immune system produces excessive amounts of TNF-alpha, leading to tissue damage, pain, and progressive organ dysfunction.
By binding to TNF-alpha with high specificity, infliximab neutralizes both the soluble and membrane-bound forms of this cytokine, effectively dampening the overactive inflammatory response. This mechanism of action makes it effective across multiple organ systems—from joints and skin to the gastrointestinal tract and spine. Remsima is a biosimilar to the reference product Remicade, meaning it has been rigorously tested and shown to have no clinically meaningful differences in safety, purity, or potency compared to the originator biologic. It was first approved by the European Medicines Agency (EMA) in 2013, making it one of the earliest biosimilar monoclonal antibodies approved in Europe.
Remsima is approved for use in adults with the following conditions:
Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic autoimmune disease that primarily attacks the synovial lining of joints, causing pain, swelling, stiffness, and progressive joint destruction. Remsima is indicated for the treatment of active RA when conventional disease-modifying antirheumatic drugs (DMARDs), including methotrexate, have not provided adequate response. It is used in combination with methotrexate to reduce signs and symptoms, inhibit structural joint damage, and improve physical function. Clinical studies have demonstrated that infliximab plus methotrexate significantly slows radiographic progression compared to methotrexate alone.
Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that occurs in association with psoriasis. It can affect peripheral joints, the axial skeleton, tendons, and entheses. Remsima is used when prior DMARD therapy has been insufficient, helping to reduce joint inflammation, prevent structural damage, and improve quality of life. It is effective for both the articular and cutaneous manifestations of psoriatic disease.
Ankylosing Spondylitis
Ankylosing spondylitis (AS), also known as Bechterew's disease, is a chronic inflammatory condition primarily affecting the spine and sacroiliac joints. It causes persistent back pain, stiffness, and can lead to spinal fusion over time. Remsima is indicated for patients with active AS who have had an inadequate response to conventional therapy, including non-steroidal anti-inflammatory drugs (NSAIDs). Treatment reduces disease activity, improves spinal mobility, and enhances functional capacity.
Psoriasis
Psoriasis is a chronic immune-mediated skin disease characterized by well-demarcated, erythematous plaques covered with silvery scales. Remsima is indicated for adults with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant of other systemic therapies including phototherapy, methotrexate, and ciclosporin. Infliximab rapidly improves skin clearance, with many patients achieving significant reductions in Psoriasis Area and Severity Index (PASI) scores within weeks of initiating therapy.
Crohn's Disease
Crohn's disease is a chronic inflammatory bowel disease (IBD) that can affect any part of the gastrointestinal tract, most commonly the terminal ileum and colon. Remsima is indicated for the treatment of moderately to severely active Crohn's disease in adults who have not responded adequately to conventional therapies including corticosteroids and immunosuppressants. It is also indicated for fistulizing Crohn's disease—the treatment of enterocutaneous fistulas that have not responded to conventional medical or surgical management. Infliximab can induce and maintain remission, promote mucosal healing, and close draining fistulas.
Ulcerative Colitis
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by continuous inflammation of the colonic mucosa and submucosa. Remsima is indicated for the treatment of moderately to severely active UC in adults who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine. Treatment with infliximab induces clinical remission, promotes mucosal healing, and reduces the need for colectomy.
What Should You Know Before Taking Remsima?
Contraindications
You must not receive Remsima if any of the following apply:
- You are allergic to infliximab, murine (mouse-derived) proteins, or any of the other ingredients
- You have tuberculosis (TB) or another serious active infection such as pneumonia or sepsis
- You have moderate or severe heart failure (NYHA Class III/IV)
If any of the above conditions apply, it is essential that you inform your doctor before treatment is considered. Infliximab can worsen heart failure and carries a significant risk of reactivating latent infections, making these absolute contraindications critically important for patient safety. Your healthcare provider will conduct a thorough assessment of your medical history before prescribing Remsima.
Warnings and Precautions
Talk to your doctor before or during treatment with Remsima if you have any of the following conditions or concerns. These warnings reflect the serious nature of TNF-inhibitor therapy and the importance of ongoing monitoring:
Previous infliximab treatment: If you have previously received any medicine containing infliximab and are restarting treatment after a break of more than 16 weeks, there is an increased risk of allergic reactions (including delayed hypersensitivity reactions). Inform your doctor about your full treatment history.
Infections: TNF inhibitors suppress immune function, which increases susceptibility to infections. Patients aged 65 and older are at particularly higher risk. You must tell your doctor immediately if you develop signs of infection during treatment, including fever, cough, flu-like symptoms, malaise, warm or reddened skin, wounds, or dental problems. Your doctor may recommend temporarily stopping treatment. If you have ever lived in or traveled to regions where histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, inform your doctor, as these fungal infections can affect the lungs or other organs.
Tuberculosis (TB): Screening for latent TB is mandatory before starting Remsima. Cases of active TB have been reported in patients receiving infliximab, even those who have completed prior TB treatment. Your doctor will test you for TB and document the results. If latent TB is detected, you will receive prophylactic TB therapy before Remsima is initiated. During treatment, report any persistent cough, weight loss, fatigue, fever, or night sweats immediately.
Hepatitis B virus (HBV): Your doctor should test you for hepatitis B before treatment. TNF inhibitors can cause reactivation of HBV in carriers, which can be life-threatening. If hepatitis B reactivates during treatment, your doctor may need to discontinue Remsima and initiate appropriate antiviral therapy.
Heart problems: Inform your doctor if you have any heart conditions, including mild heart failure. Infliximab should be used with extreme caution in patients with mild heart failure and is contraindicated in moderate or severe heart failure. Report any new or worsening symptoms such as shortness of breath, swelling of the feet, or chest discomfort immediately.
Cancer and lymphoma: Patients with severe, long-standing rheumatoid arthritis may have an increased baseline risk of lymphoma. Treatment with TNF inhibitors, including infliximab, has been associated with an increased risk of lymphoma and other malignancies. A rare form of hepatosplenic T-cell lymphoma has been reported, predominantly in adolescent and young adult males with inflammatory bowel disease who were also receiving azathioprine or mercaptopurine. Some patients have developed skin cancers (including melanoma) and cervical cancer during infliximab therapy. Regular skin examinations and cervical cancer screening (for women) are recommended.
Lung disease or heavy smoking: Patients with chronic obstructive pulmonary disease (COPD) or those who are heavy smokers may have a higher risk of developing cancer during treatment. Discuss your smoking history with your doctor.
Nervous system disorders: Inform your doctor if you have or have ever had conditions affecting the nervous system, including multiple sclerosis, Guillain-Barré syndrome, seizures, or optic neuritis. Report any changes in vision, weakness in arms or legs, numbness, or tingling during treatment.
Vaccinations: You should receive all recommended vaccinations before starting Remsima. Live vaccines (those containing weakened but living organisms) must not be administered during treatment, as they may cause serious infections in immunosuppressed patients. If you received Remsima during pregnancy, your infant must not receive live vaccines (such as BCG) for at least 12 months after birth. If you are breastfeeding while using Remsima, inform your child's doctor before any vaccinations are given.
Liver problems: Serious liver problems, including liver failure, have been reported with infliximab. Contact your doctor immediately if you experience yellowing of the skin or eyes, dark brown urine, pain or swelling in the upper right abdomen, joint pain, skin rash, or fever.
Low blood counts: In some patients receiving infliximab, the body may not produce enough blood cells to fight infections or stop bleeding. Report persistent fever, easy bruising or bleeding, pale skin, or small red or purple spots under the skin to your doctor.
Injection site reactions: Patients receiving subcutaneous Remsima may experience local reactions at the injection site, including redness, pain, itching, swelling, hardening, bruising, or blistering. Most reactions are mild to moderate and typically resolve within a day.
Pregnancy and Breastfeeding
Remsima should only be used during pregnancy if your doctor determines it is clearly necessary. You should avoid becoming pregnant while being treated with Remsima and for at least 6 months after your last dose. Discuss the use of appropriate contraception with your doctor during this period.
If you received Remsima during pregnancy, your baby may have a higher risk of infection due to immune suppression. It is critically important to inform your baby's healthcare providers about your Remsima use. Your infant must not receive live vaccines (including BCG) for at least 12 months after birth unless your baby's doctor specifically advises otherwise. Severely reduced white blood cell counts have been reported in infants born to women treated with infliximab during pregnancy.
Infliximab is excreted in breast milk in small amounts. If you are breastfeeding, discuss the risks and benefits with your doctor. Inform your child's healthcare team about your Remsima use before your baby receives any vaccine.
Remsima is not expected to affect your ability to drive or operate machinery. However, if you feel tired, dizzy, or unwell after receiving Remsima, you should not drive or use tools or machines until you feel better.
How Does Remsima Interact with Other Drugs?
Patients with inflammatory and autoimmune diseases are often taking multiple medications simultaneously. When starting Remsima, your doctor will advise which current medications should be continued, adjusted, or discontinued. It is important to inform your doctor about all medicines you are taking, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements.
Major Interactions (Avoid Combination)
| Drug | Interaction | Risk Level |
|---|---|---|
| Anakinra (Kineret) | Increased risk of serious infections and neutropenia; no additional clinical benefit demonstrated | Contraindicated |
| Abatacept (Orencia) | Increased risk of serious infections due to dual immunosuppression; no added efficacy | Contraindicated |
| Live Vaccines (BCG, MMR, Varicella, Rotavirus, Oral Polio) | Risk of vaccine-related infection due to immunosuppression; live organisms may cause disseminated disease | Contraindicated |
| Other TNF Inhibitors (Adalimumab, Etanercept, Certolizumab, Golimumab) | Excessive immunosuppression with significantly increased infection and malignancy risk | Contraindicated |
Interactions Requiring Monitoring
| Drug | Interaction | Clinical Note |
|---|---|---|
| Methotrexate | Commonly co-prescribed; reduces formation of anti-drug antibodies and improves efficacy | Standard combination for RA; monitor liver function and blood counts |
| Azathioprine / 6-Mercaptopurine | Increased risk of hepatosplenic T-cell lymphoma, especially in young males with IBD | Weigh benefits vs. risk; regular monitoring required |
| Corticosteroids | Additive immunosuppression; may increase infection risk | Taper steroids when possible once remission is achieved |
| Warfarin / Anticoagulants | Monitor INR closely; infliximab may affect warfarin metabolism through cytokine modulation | Adjust anticoagulant dose based on INR monitoring |
If you are unsure whether any of your medications may interact with Remsima, consult your doctor, pharmacist, or nurse. Never start, stop, or change the dose of any medication without discussing it with your healthcare provider first.
What Is the Correct Dosage of Remsima?
Always use Remsima exactly as your doctor has prescribed. Your treatment regimen will depend on the specific condition being treated. Remsima is available in two formulations: a powder for intravenous (IV) infusion and a pre-filled pen for subcutaneous (SC) injection. It is critical to verify the correct formulation before each dose.
Adults
Rheumatoid Arthritis
Induction: Your doctor may start treatment with or without two IV infusions of infliximab at 3 mg/kg body weight, administered over approximately 2 hours, given 2 weeks apart. If IV induction is used, the first subcutaneous dose begins 4 weeks after the last IV infusion. If starting directly with subcutaneous injections: 120 mg SC at weeks 0, 1, 2, 3, and 4, then every 2 weeks thereafter.
Maintenance: 120 mg subcutaneously every 2 weeks (regardless of body weight). Always used in combination with methotrexate.
Psoriatic Arthritis, Ankylosing Spondylitis & Psoriasis
Induction: Two IV infusions of infliximab at 5 mg/kg body weight, given 2 weeks apart. The first subcutaneous dose begins 4 weeks after the last IV infusion.
Maintenance: 120 mg subcutaneously every 2 weeks (regardless of body weight).
Crohn's Disease & Ulcerative Colitis
Induction: Two or three IV infusions of infliximab at 5 mg/kg body weight, given 2 weeks apart. An additional third IV infusion may be given 4 weeks after the second infusion, at the doctor's discretion. The first subcutaneous dose begins 4 weeks after the last IV infusion.
Maintenance: 120 mg subcutaneously every 2 weeks (regardless of body weight).
The first subcutaneous injection will be given under medical supervision. After receiving proper training, your doctor may allow you to self-inject Remsima at home. The pre-filled pen (120 mg) can be injected into the front of the thighs, the abdomen (at least 5 cm from the navel), or the outer upper arms (caregivers only). Rotate injection sites and keep each new site at least 3 cm from the previous one.
Children
The subcutaneous formulation of Remsima (pre-filled pen) has not been approved for use in children and adolescents under 18 years of age. There is insufficient data to demonstrate safety and efficacy in this age group for the subcutaneous route. Intravenous infliximab may be used in children aged 6 years and older for Crohn's disease and ulcerative colitis under specialist supervision—consult your doctor for detailed paediatric dosing guidance.
Elderly
No specific dose adjustment is required for elderly patients. However, patients aged 65 and older are at increased risk of infections during TNF-inhibitor therapy. Close monitoring is recommended, and treatment should only be continued if the benefits clearly outweigh the risks.
Missed Dose
If you miss a dose of Remsima:
- Missed by up to 7 days: Take the missed dose immediately. Then take your next dose on the originally scheduled date and continue with your regular dosing schedule.
- Missed by 8 days or more: Do not take the missed dose. Take your next dose on the originally scheduled date and continue with your regular dosing schedule.
If you are unsure when to inject, contact your doctor or nurse for guidance.
Overdose
If you inject too much Remsima (either too large a dose at one time or too frequently), contact your doctor, pharmacist, or nurse immediately. Bring the medicine packaging with you, even if it is empty. No specific antidote exists for infliximab overdose; treatment is supportive and symptomatic. Single doses of up to 20 mg/kg intravenously have been administered without direct toxic effects in clinical studies.
What Are the Side Effects of Remsima?
Most side effects of Remsima are mild to moderate. However, some patients may experience serious adverse events that require immediate medical attention. Side effects may also occur after treatment with Remsima has ended. The following lists categorize side effects by frequency, based on clinical trial data and post-marketing surveillance.
- Signs of allergic reaction: swelling of face, lips, mouth, or throat; difficulty breathing or swallowing; skin rash, hives, or swollen hands/feet
- Signs of serious infection: fever, persistent cough, shortness of breath, weight loss, night sweats, warm or reddened skin
- Signs of heart problems: chest pain or discomfort, shortness of breath, swelling of feet, rapid or slow heartbeat, fainting
- Signs of liver damage: yellowing of skin or eyes, dark urine, upper right abdominal pain
- Signs of neurological problems: sudden numbness or weakness (especially on one side), vision changes, difficulty walking or speaking
- Signs of cancer: unexplained weight loss, swollen lymph nodes, unusual lumps or skin changes
Very Common
May affect more than 1 in 10 people
- Viral infections (herpes, influenza)
- Upper respiratory infections (sinusitis)
- Headache
- Abdominal pain, nausea
- Injection-related reactions
- Pain
Common
May affect up to 1 in 10 people
- Lower respiratory infections (bronchitis, pneumonia)
- Urinary tract infections
- Bacterial infections (sepsis, abscess, cellulitis)
- Fungal skin infections
- Anaemia, low white blood cell count
- Swollen lymph nodes
- Depression, insomnia
- Dizziness, balance problems
- Eye problems (redness, infections)
- Rapid heartbeat (tachycardia), palpitations
- Low or high blood pressure
- Nosebleeds, flushing, bruising
- Difficulty breathing, chest pain
- Diarrhoea, dyspepsia, heartburn, constipation
- Gastrointestinal bleeding
- Liver enzyme elevation
- Hives (urticaria), itchy rash, dry skin
- Psoriasis, eczema, hair loss
- Joint pain, muscle pain, back pain
- Fatigue, weakness
- Fever, increased sweating
- Injection site reactions (pain, swelling, redness)
- Chills, oedema
- Numbness, tingling
Uncommon
May affect up to 1 in 100 people
- Tuberculosis
- Severe allergic reaction (anaphylaxis)
- Lupus-like syndrome
- New or worsening heart failure
- Fainting, seizures
- Nerve problems, memory loss
- Blurred or decreased vision
- Intestinal perforation or obstruction
- Pancreatitis
- Kidney infections
- Low platelet count, excessive white blood cells
- Pleural effusion, pulmonary oedema
- Airway narrowing causing breathing difficulty
- Impaired wound healing
- Cholesterol and lipid changes
- Weight gain
Rare
May affect up to 1 in 1,000 people
- Lymphoma (blood cancer)
- Melanoma (skin cancer)
- Cervical cancer
- Hepatitis B reactivation
- Autoimmune hepatitis
- Jaundice
- Meningitis
- Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Vasculitis (inflammation of blood vessels)
- Sarcoidosis
- Transverse myelitis, MS-like disease, optic neuritis, Guillain-Barré syndrome
- Pericardial effusion
- Interstitial lung disease
- Severely reduced white blood cell counts
Frequency Not Known
Cannot be estimated from available data
- Hepatosplenic T-cell lymphoma (mainly in young males with IBD)
- Liver failure
- Merkel cell carcinoma (skin cancer)
- Kaposi's sarcoma
- Heart attack, stroke
- Temporary vision loss during or within 2 hours of infusion
- Worsening of dermatomyositis
- Infection from live vaccines due to weakened immune system
If you notice any side effects not listed here, or if any of the listed effects become serious, please tell your doctor, pharmacist, or nurse. Reporting suspected adverse reactions helps with ongoing monitoring of the medicine's benefit-risk balance.
How Should You Store Remsima?
Proper storage is essential to maintain the safety and efficacy of Remsima. Follow these guidelines carefully:
- Keep this medicine out of the sight and reach of children.
- Do not use after the expiry date printed on the label and carton after "EXP." The expiry date refers to the last day of that month.
- Refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze. If frozen, do not use the pen.
- Keep the pre-filled pen in the outer carton to protect from light.
- The pen may be stored outside the refrigerator at up to 25°C (77°F) for a single period of up to 28 days, but must not exceed the original expiry date. Write the new use-by date on the carton. Once removed from the refrigerator, do not return it to refrigerated storage.
- Do not use if the solution appears cloudy, discoloured, or contains particles. The solution should be clear to opalescent, colourless to light brown. Small air bubbles are normal.
- Do not dispose of medicines in wastewater or household waste. Return unused medicines to your pharmacy for safe disposal.
What Does Remsima Contain?
Understanding the composition of your medicine helps you identify any potential allergens and ensures safe use.
Active Ingredient
Each 1 mL single-dose pre-filled pen contains 120 mg infliximab, a chimeric IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Inactive Ingredients (Excipients)
- Acetic acid
- Sodium acetate trihydrate
- Sorbitol (E420) — 45 mg per 120 mg dose
- Polysorbate 80 (E433) — 0.5 mg per vial (note: polysorbates can cause allergic reactions in sensitive individuals)
- Water for injections
This medicine contains less than 1 mmol (23 mg) sodium per dose unit, meaning it is essentially sodium-free.
Appearance
Remsima subcutaneous injection is a clear to opalescent, colourless to light brown solution supplied in a single-use pre-filled pen. Each pack contains 1, 2, 4, or 6 pre-filled pens with alcohol swabs. Not all pack sizes may be available in your country.
Marketing authorisation holder: Celltrion Healthcare Hungary Kft., 1062 Budapest, Váci út 1-3, WestEnd Office Building B Tower, Hungary.
Frequently Asked Questions About Remsima
Remsima contains infliximab, a monoclonal antibody that belongs to a group of medicines called TNF inhibitors. It works by binding to and blocking tumor necrosis factor alpha (TNF-alpha), a protein that promotes inflammation in the body. By neutralizing TNF-alpha, Remsima reduces inflammation in conditions such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, and ankylosing spondylitis. Remsima is a biosimilar to Remicade and has been shown to have equivalent safety and efficacy.
Remsima is a biosimilar of Remicade. Both contain infliximab as the active ingredient and work through the same mechanism of action. Biosimilars undergo rigorous testing to demonstrate they are highly similar to the reference medicine with no clinically meaningful differences in safety, purity, or efficacy. Remsima was approved by the EMA in 2013 and the FDA in 2016, and has been used extensively worldwide with established safety and efficacy data.
Yes, after appropriate training from your healthcare provider. The Remsima 120 mg pre-filled pen is designed for subcutaneous self-injection. Your first injection will be administered under medical supervision. Once you feel confident and have been properly trained, your doctor may allow you to self-inject at home. You can inject into the front of your thighs or abdomen (at least 5 cm from the navel). Rotate injection sites each time, keeping at least 3 cm between sites. Always follow the detailed injection instructions provided with the pen.
Yes, screening for tuberculosis (TB) is mandatory before starting Remsima. TNF inhibitors like infliximab can reactivate latent TB infections, which can be serious and even life-threatening. Your doctor will perform a TB test (typically a tuberculin skin test or interferon-gamma release assay) and may also order a chest X-ray. If latent TB is detected, you will receive prophylactic TB treatment before beginning Remsima. You should also be tested for hepatitis B before treatment, as infliximab can cause HBV reactivation.
If you miss a dose by up to 7 days, take the missed dose immediately and then continue with your regular schedule. If you miss a dose by 8 days or more, skip the missed dose and take your next dose on the originally scheduled date. Do not take a double dose to make up for a missed one. If you are unsure about when to inject, contact your doctor or nurse for guidance.
You should receive all recommended vaccinations before starting Remsima. During treatment, you may receive inactivated vaccines (such as the flu shot or COVID-19 vaccines), but you must not receive live vaccines (such as BCG, MMR, varicella, oral polio, or rotavirus). Live vaccines contain weakened organisms that could potentially cause infection in people with suppressed immune systems. If you were pregnant during treatment, your baby must not receive live vaccines for at least 12 months after birth.
References
- European Medicines Agency (EMA). Remsima—Summary of Product Characteristics. Last updated November 2025. Available at: EMA EPAR: Remsima.
- Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613-1620. doi:10.1136/annrheumdis-2012-203090.
- Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72(10):1605-1612. doi:10.1136/annrheumdis-2012-203091.
- National Institute for Health and Care Excellence (NICE). TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis. Technology appraisal guidance [TA383]. Updated 2023.
- Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3-18. doi:10.1136/ard-2022-223356.
- Torres J, Bonovas S, Doherty G, et al. ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. J Crohns Colitis. 2020;14(1):4-22. doi:10.1093/ecco-jcc/jjz180.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. 2023. Available at: WHO Essential Medicines.
- U.S. Food and Drug Administration (FDA). Biosimilar Product Information: Infliximab Products. Available at: FDA Biosimilars.
Editorial Team
This article has been reviewed by the iMedic Medical Review Board, an independent panel of board-certified physicians specialising in rheumatology, gastroenterology, dermatology, and clinical pharmacology. All medical content adheres to international treatment guidelines (EULAR, ECCO, NICE, ACR) and the GRADE evidence framework.
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