Chemicals and Drugs
Antibodies, Monoclonal
InflectraHumiraRenflexisSecond Remicade biosimilarEnbrelMonoclonal antibodyCombination with methotrexateJohnson's RemicadeRheumatoidCrohn'sPsoriasisPfizerDosageJanssen BiotechVialBiologicInfusionMerckSamsung BioepisBiosimilar infliximabDMARDJohnsonInflammatoryIndicationsDiseasesEfficacyImmune systemAnticompetitivePsoriaticUlcerative colitisAntibodies2017ApprovalTumorSide EffectsSymptomsDrugHealthcare providersTreatmentInfectionsDrugmakerInteract
Inflectra15
  • Remicade, Inflectra, more. (medscape.com)
  • Reuters)-The U.S. Food and Drug Administration on Tuesday approved Inflectra, a cheaper version of Johnson & Johnson's drug Remicade ( infliximab ), to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine. (the-rheumatologist.org)
  • Inflectra, also known as infliximab-dyyb, is expected by some analysts to sell for a 25% discount to Remicade, which generated annual worldwide sales of $6.5 billion. (the-rheumatologist.org)
  • The use of biosimilars for rheuma-tology in the U.S. became a reality when the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), in April. (the-rheumatologist.org)
  • Amgen's Amgevita was the first biosimilar of mega blockbuster Humira to win approval in Europe in March this year, while Hospira's Inflectra was the first biosimilar of Remicade to be approved back in 2013. (biopharmabusiness.com)
  • Pfizer said it will not launch Ixifi (infliximab-qbtx), the biosimilar to Johnson & Johnson's Remicade in the US, since the drugmaker already sells the biosimilar infliximab-dyyb (Inflectra), Regulatory Focus reported . (formularywatch.com)
  • Ixifi is the Remicade biosimilar that Pfizer developed prior to the company's acquisition of Hospira in 2015, a Pfizer spokesperson told Regulatory Focus , while Hospira and Celltrion had developed Inflectra. (formularywatch.com)
  • Given this multi-channel approach, along with a 15% price discount vs. Remicade, Pfizer could anticipate capturing significant market share with Inflectra. (remapconsulting.com)
  • However, Inflectra has struggled to make a dent in Remicade sales. (remapconsulting.com)
  • Overall, the comprehensive nature of J&Js defense has successfully staved off Inflectra, with Remicade sales decreasing by a mere 5% in the second quarter of 2017. (remapconsulting.com)
  • The FDA approved Celltrion's version of Remicade, marketed as Inflectra, in early April. (biopharmadive.com)
  • However, Johnson & Johnson, the producer of brand name Remicade, has said it will defend its intellectual property rights in the event Celltrion attempts to market Inflectra before September 2018, when the last of its patents expire. (biopharmadive.com)
  • Yesterday, Pfizer commenced suit against J&J and Jannsen in the US District Court for the Eastern District of Pennsylvania, alleging J&J engaged in anti-competitive behaviour relating to Remicade™, preventing the uptake of Pfizer's biosimilar infliximab, Inflectra™, launched in 2016. (pearceip.law)
  • As reported in the previous article , the Federal Court found that Kennedy's new use patent for infliximab (Janssen's REMICADE ) was valid and infringed by Hospira's biosimilar INFLECTRA . (smartbiggar.ca)
  • There is environmental information about infliximab from Pfizer (Inflectra), MSD (Remicade) och Orion Pharma (Remsima), downloaded 2023-10-24. (janusinfo.se)
Humira8
  • Remicade ( infliximab ) and Humira ( adalimumab ) are both laboratory-synthesized proteins. (hdkino.org)
  • After all, the express goal of both Remicade and Humira is to suppress the immune system. (hdkino.org)
  • What are Remicade and Humira? (hdkino.org)
  • Remicade and Humira are injectable monoclonal antibodies (a type of synthesized protein made from cells in a lab) in the class of medications called TNF blockers or TNF inhibitors. (hdkino.org)
  • In autoimmune diseases like rheumatoid arthritis , psoriatic arthritis , Crohn's disease , psoriasis and the other conditions Remicade and Humira are approved to treat, the immune system mistakes the body's own cells for foreign ones and attacks them, causing inflammation, pain , tissue destruction and other associated symptoms. (hdkino.org)
  • Remicade, Humira and the other members of the TNF inhibitor class are different types of protein molecules all designed to achieve the same goal: binding to the TNF alpha molecules to render them harmless, thereby reducing inflammation, whether it's in the joints, skin, or bowels. (hdkino.org)
  • Neither Remicade nor Humira can cure any of the diseases for which they're approved as treatment, but each medication can dramatically reduce the symptoms, such as joint pain . (hdkino.org)
  • European regulators have accepted for review Sandoz' marketing applications for biosimilars to AbbVie's Humira (adalimumab) and Janssen's Remicade (infliximab). (biopharmabusiness.com)
Renflexis2
  • in the United States, the company is responsible for selling Renflexis , a biosimilar infliximab developed by Samsung Bioepis that competes with Remicade (although the drug is marketed by Biogen in the EU under the name Flixabi ). (centerforbiosimilars.com)
  • There is another cog in the wheel that is limiting the marketing of biosimilars to Remicade, which include infliximab-abda (Renflexis, Merck and Samsung). (formularywatch.com)
Second Remicade biosimilar1
Enbrel1
  • In addition to its Remicade copy, Samsung has also won E.U. approval for a biosimilar version of Pfizer's Enbrel. (biopharmadive.com)
Monoclonal antibody2
  • Remicade is a chimeric monoclonal antibody that is used to treat a range of autoimmune disorders, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis. (expertlegals.com)
  • Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. (wikipedia.org)
Combination with methotrexate6
  • REMICADE®, in combination with methotrexate, is a prescription medication for adults living with moderately to severely active rheumatoid arthritis. (remicade.com)
  • Remicade should be given in combination with methotrexate. (healthdirect.gov.au)
  • Remicade may be administered in combination with methotrexate. (healthdirect.gov.au)
  • REMICADE ® , in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA). (janssencarepath.com)
  • In cases of HS, Remicade is often prescribed in combination with methotrexate . (myhsteam.com)
  • The phase 3, multinational study evaluated the safety, efficacy, and immunogenicity of Ixifi versus Remicade administered intravenously in combination with methotrexate to treat patients with moderate to severely active RA who have had an inadequate response to methotrexate therapy. (formularywatch.com)
Johnson's Remicade1
  • Remsima is a biosimilar drug of Johnson & Johnson's Remicade. (medindia.net)
Rheumatoid6
  • Remicade helps in the treatment of rheumatoid arthritis, Crohn's disease and ulcerative colitis. (medindia.net)
  • Remicade is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, rheumatoid arthritis, and inflammatory bowel disease. (myhsteam.com)
  • Certain drugs for rheumatoid arthritis - Some of the drugs for rheumatoid arthritis can potentiate the action of Remicade, possibly increasing your risk for infection. (drugsdb.com)
  • Remicade and the biosimilar versions treat rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis, and other inflammatory conditions. (formularywatch.com)
  • Remicade (infliximab) is a biologic medication that is primarily used to treat autoimmune diseases, such as rheumatoid arthritis, Crohn's disease, and psoriasis. (writeupcafe.com)
  • North America: The North American market for Remicade is the largest due to a high prevalence of autoimmune diseases such as rheumatoid arthritis and Crohn's disease, well-established healthcare infrastructure, and high healthcare spending. (writeupcafe.com)
Crohn's5
  • Crohn's Disease in Adults and in Children and adolescents (6-17 years): Remicade is indicated for the treatment of moderate to severe Crohn's disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies. (healthdirect.gov.au)
  • Refractory Fistulising Crohn's Disease: Remicade is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients. (healthdirect.gov.au)
  • Remicade represents a paradigm in treatment for Crohn's disease. (endo-world.com)
  • There have been case reports of patients experiencing severe and fatal form of cancer called hepatosplenic T-cell lymphoma following concomitant use of azathioprine and Remicade particularly among young males being treated for ulcerative colitis and Crohn's disease. (drugsdb.com)
  • My husband takes Remicade for Crohn's Disease. (medhelp.org)
Psoriasis3
  • Remicade is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. (healthdirect.gov.au)
  • REMICADE ® is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis (Ps) who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. (janssencarepath.com)
  • Medications and phototherapy for psoriasis - Certain medications for psoriasis have the same effects as with Remicade. (drugsdb.com)
Pfizer1
  • This fall, Pfizer sued Johnson & Johnson over exclusionary contracts that Pfizer said were limiting its ability to gain Remicade market share, Regulatory Focus reported. (formularywatch.com)
Dosage2
  • Your doctor will determine the right dosage of REMICADE® for you and how often you should receive it. (remicade.com)
  • If your REMICADE® dosage is increased, it is important to talk with your doctor about the increased possibility of infection. (remicade.com)
Janssen Biotech1
  • Studies have shown Zessly to have "comparable quality, safety and efficacy" to the reference product Remicade (infliximab, Janssen Biotech, Inc), the EMA said in a statement. (medscape.com)
Vial1
Biologic3
  • REMICADE® belongs to a class of biologic medications known as tumor necrosis factor (TNF)-alpha blockers. (remicade.com)
  • Remicade and Neupogen are biologic drugs made from living organisms. (the-rheumatologist.org)
  • Within the pharmaceutical industry, Remicade would be classified as a biologic drug product and would be marketed and distributed through various channels, including wholesalers, distributors, and retailers. (writeupcafe.com)
Infusion7
  • REMICADE® is given as an intravenous (IV) infusion by a healthcare professional through a needle placed in a vein in your arm. (remicade.com)
  • At the time, I was worried that I had built antibodies to the Remicade, but when I finally received my infusion, everything went back to normal. (crohnsforum.com)
  • As of right now, my next Remicade infusion is in two weeks, and as of today, my stools are starting to become loose again. (crohnsforum.com)
  • Ok, so I got ahold of the doctor and from the previous infusion, my remicade level was at 3.7. (crohnsforum.com)
  • After initial loading doses, Remicade is administered every eight weeks by intravenous infusion in a clinical setting. (myhsteam.com)
  • The FDA-approved label for Remicade lists common side effects including infections (e.g. upper respiratory infections, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain. (myhsteam.com)
  • The clinical significance of apparent increased immunogenicity on efficacy and infusion reactions in Ps patients as compared to patients with other diseases treated with REMICADE over the long term is not known. (medlibrary.org)
Merck2
  • KENILWORTH, N.J. - Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade. (merck.com)
  • Of that, $4.5 billion were in the U.S. Merck & Co. sells Remicade in Europe. (the-rheumatologist.org)
Samsung Bioepis2
  • Samsung Bioepis said Tuesday the FDA will review its application to market a copy of the blockbuster anti-inflammatory drug Remicade (infliximab). (biopharmadive.com)
  • Samsung Bioepis applies for approval to sell Remicade biosimilar in U.S. (biopharmadive.com)
Biosimilar infliximab1
  • Samsung conducted Phase 1 and Phase 3 studies to test to equivalence of its biosimilar infliximab to branded Remicade, demonstrating comparable safety and efficacy. (biopharmadive.com)
DMARD1
  • Remicade is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (DMARD) therapy. (healthdirect.gov.au)
Johnson3
  • The statement from J&J reads that, "We believe that the data to date, absent of direct comparisons of CT-P13 and REMICADE in patients with inflammatory bowel disease, leave uncertainty about whether differences in safety or efficacy may emerge for patients," said Jay Siegel, M.D., Chief Biotechnology Officer and Head, Scientific Strategy and Policy at Johnson & Johnson. (medindia.net)
  • The Canadian case involved Janssen, a division of Johnson & Johnson, which sells the brand-named Remicade in Canada, the United States, and other markets. (centerforbiosimilars.com)
  • In a separate matter, Johnson & Johnson (J&J) announced receipt of a further action from the US Patent and Trademark Office regarding the re-examination of US Patent No. 6,284,471 ('471) relating to Remicade, issuing a final rejection of the patent. (dcatvci.org)
Inflammatory1
  • The use of Remicade does seem to be very much more specific in dealing with the tumor necrosis factor - a major cytokine that modulates that actual inflammatory response. (endo-world.com)
Indications1
  • The application seeks approval for use in all therapeutic indications currently approved for Remicade for which marketing exclusivity has expired. (merck.com)
Diseases8
  • Biosimilar Remicade could soon be in the cards for treating arthritis and bowel diseases as the FDA supports its approval this year. (medindia.net)
  • But the FDA has recommended the biosimilar drug to be approved for treating autoimmune diseases similar to that of the drug Remicade. (medindia.net)
  • The size of the Remicade market segment would depend on the demand for the medication and the number of patients who are diagnosed with autoimmune diseases that are treated with the drug. (writeupcafe.com)
  • Overall, the Remicade market segment is likely to be relatively large, as autoimmune diseases are common and can have a significant impact on patients' quality of life. (writeupcafe.com)
  • Europe: The European market for Remicade is significant due to a high prevalence of autoimmune diseases and the presence of major pharmaceutical companies in the region. (writeupcafe.com)
  • Asia Pacific: The Asia Pacific market for Remicade is expected to grow significantly due to an increase in the prevalence of autoimmune diseases, an increase in healthcare spending, and an improvement in healthcare infrastructure. (writeupcafe.com)
  • Latin America: The Latin American market for Remicade is driven by an increase in the prevalence of autoimmune diseases and an increase in healthcare spending. (writeupcafe.com)
  • Overall, the global market for Remicade is expected to grow significantly in the coming years, driven by factors such as an increase in the prevalence of autoimmune diseases and an increase in healthcare spending in emerging markets. (writeupcafe.com)
Efficacy1
  • These agreements incentivized insurers to prefer Remicade over its competitors, even if those competitors offered similar or better efficacy at lower prices. (expertlegals.com)
Immune system3
  • Remicade is an immunomodulator, a drug that modulates the immune system. (myhsteam.com)
  • Remicade is a genetically engineered antibody, or protein used by the immune system to identify and neutralize substances. (myhsteam.com)
  • Since Remicade lowers your immune system, receiving live vaccines can potentially get you infected with the virus or disease. (drugsdb.com)
Anticompetitive4
  • The United Kingdom's Competition and Markets Authority has closed an investigation into an alleged anticompetitive discount scheme related to brand-name infliximab, Remicade. (centerforbiosimilars.com)
  • The end of the investigation comes just weeks after a Canadian investigation into alleged anticompetitive practices related to Remicade was also closed. (centerforbiosimilars.com)
  • The plaintiffs, a group of consumers and third-party payors, claimed that these anticompetitive practices resulted in artificially inflated prices for Remicade, causing them to pay more for the drug than they should have. (expertlegals.com)
  • The settlement of the Remicade class action lawsuit serves as a reminder of the potential consequences of anticompetitive practices in the pharmaceutical industry. (expertlegals.com)
Psoriatic1
  • REMICADE ® is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in adult patients with psoriatic arthritis (PsA). (janssencarepath.com)
Ulcerative colitis2
  • Remicade is indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy. (healthdirect.gov.au)
  • REMICADE ® is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy. (janssencarepath.com)
Antibodies4
  • Treatment with REMICADE can be associated with the development of antibodies to infliximab. (medlibrary.org)
  • An enzyme immunoassay (EIA) method was originally used to measure anti-infliximab antibodies in clinical studies of REMICADE. (medlibrary.org)
  • The incidence of antibodies to infliximab was based on the original EIA method in all clinical studies of REMICADE except for the Phase 3 study in pediatric patients with UC where the incidence of antibodies to infliximab was detected using both the EIA and ECLIA methods. (medlibrary.org)
  • The incidence of antibodies to infliximab in patients with RA and CD given a 3-dose induction regimen followed by maintenance dosing was approximately 10% as assessed through 1 to 2 years of REMICADE treatment. (medlibrary.org)
20171
Approval1
  • Adverse reactions, some with fatal outcomes, have been identified during post approval use of REMICADE in adult and pediatric patients. (medlibrary.org)
Tumor2
  • Remicade, as well as similar drugs made by AbbVie Inc. and Amgen Inc., work by blocking an inflammation-causing protein called tumor necrosis factor. (the-rheumatologist.org)
  • Remicade is believed to work by inhibiting tumor necrosis factor alpha (TNF-alpha), a chemical messenger involved in autoimmune attacks. (myhsteam.com)
Side Effects2
  • These drugs can either potentiate or reduce the pharmacologic action of Remicade, and possibly increasing your risk for side effects. (drugsdb.com)
  • Combining them with Remicade can potentiate the effects of the drug possibly increasing the risk of side effects. (drugsdb.com)
Symptoms4
  • Remicade is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease. (healthdirect.gov.au)
  • REMICADE ® is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active CD who have had an inadequate response to conventional therapy. (janssencarepath.com)
  • REMICADE ® is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS). (janssencarepath.com)
  • Closely monitor patients for the development of signs and symptoms of infection during and after treatment with REMICADE ® , including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection. (janssencarepath.com)
Drug5
  • Remicade may be referred to by its drug name, infliximab. (myhsteam.com)
  • Certain immunosuppresant drug - Caution should be taken when using Remicade with other immunosuppresants. (drugsdb.com)
  • This drug information guide may not contain all the drugs that can potentially interact with Remicade. (drugsdb.com)
  • The US Food and Drug Administration (FDA) postponed the March 17 meeting of its Arthritis Advisory Committee, explaining that the review of Celltrion's Remicade biosimilar - CT-P13 - would be rescheduled. (biopharma-reporter.com)
  • In the realm of pharmaceuticals, Remicade stands as a prominent drug, used to treat a range of autoimmune disorders. (expertlegals.com)
Healthcare providers2
  • The market segment for Remicade would primarily be the pharmaceutical industry and healthcare providers, including hospitals, clinics, and pharmacies. (writeupcafe.com)
  • In addition to healthcare providers and the pharmaceutical industry, the Remicade market segment may also include insurance companies, as they may cover some or all of the cost of the medication for patients who have insurance coverage. (writeupcafe.com)
Treatment2
  • The risks and benefits of treatment with REMICADE ® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. (janssencarepath.com)
  • Therefore, people on Remicade treatment should not receive live vaccinations throughout the treatment. (drugsdb.com)
Infections3
  • REMICADE® can lower your ability to fight infections. (remicade.com)
  • Patients treated with REMICADE ® (infliximab) are at increased risk for developing serious infections that may lead to hospitalization or death. (janssencarepath.com)
  • In clinical trials, other serious infections observed in patients treated with REMICADE ® included pneumonia, cellulitis, abscess, and skin ulceration. (janssencarepath.com)
Drugmaker1
  • The US FDA has delayed an advisory committee review of Celltrion's Remicade (infliximab) biosimilar after asking the South Korean drugmaker for more information. (biopharma-reporter.com)
Interact1
  • Some medications are known to interact with Remicade. (drugsdb.com)