Currently, seven biosimilars have been approved by the United States Food and Drug Administration (FDA) for use in Crohn’s disease, ulcerative colitis, and colorectal cancer. ![]() This ultimately reduces the cost of production and the cost of the biosimilar drug compared to its reference biologic. Although the manufacturing process still involves production within living cells, biosimilars undergo fewer clinical trials than do their reference biologics. Biosimilars must be nearly identical to their reference biologics in terms of efficacy, side effect risk profile, and immunogenicity. The development of biosimilars is an attempt to reduce treatment costs. While biologics have proven to be effective in treating or managing many diseases, patient access is often limited by high costs. Within the field of gastroenterology alone, biologics are used to treat inflammatory bowel diseases, cancers, and endocrine disorders. Biologics are created in living cells and are typically large, complex proteins that may have a variety of uses. 77.2% patients perceived the overall therapy with Intacept as excellent, very good, good or OK while 22.8% patients rated Intacept therapy as non-satisfactory.Conclusions: The study leads to the conclusion that Intended biosimilar of etanercept (Intacept) was safe and well tolerated in various rheumatic disorders in a real-world scenario.īiosimilars are a growing drug class designed to be used interchangeably with biologics. 51.4% patients observed more than 50% improvement in global disease activity with Intacept while 10% patients did not get any response with the treatment. About 24% of patients dropped due to various reasons like affordability issue (5.7%), inadequate response (8.6%), no response (10%) and side effects (5.7%). ![]() 45% patients had LTBI screen positive and were initiated on chemoprophylaxis with Rifampicin and INH 4weeks prior to Intacept. 10% patients reported adverse events like injection site pain (4.29%), fever (2.86%), redness (1.42%) and weight gain (1.42%). ![]() ![]() The mean duration of follow up was 8☑.7 months. Basic demographic profile, disease and duration of therapy, any adverse event, patient’s global assessment of disease activity on visual analogue scale (0 to 100), patient’s overall experience with Intended biosimilar etanercept (Intacept).Results: Total 70 patients were enrolled (41males and 29 females) having RA (42), AS (11), SpA (13), JIA (2) AND PsA (2). (Intacept) in Rheumatoid arthritis (RA), spondyloarthropathy (SpA), ankylosing Spondylitis (AS), juvenile idiopathic arthritis (JIA) and psoriatic arthritis (PsA).Methods: In single center, retrospective observational study, all patients were enrolled in routine clinical practice who received Intended biosimilar of Etanercept (Intacept) and the following data was collected. The objective of the present study was to assess the safety profile of intended biosimilar of etanercept developed by Intas pharmaceuticals Ltd. Presently, the data available on the safety and effectiveness of biosimilars is very scarce. Background: Biosimilars are expected to provide affordable and quality treatment equivalent to the biologics in various rheumatic disorders.
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