Biosimilars for the Management of Inflammatory Bowel Diseases: Economic Considerations

Biological drugs revolutionized the treatment of inflammatory bowel diseases (IBD) such as Crohn’s disease and ulcerative colitis. However, not all clinically eligible patients have access to biologicals due to significant costs and budget impact. Biosimilars are highly comparable to their originator product in terms of clinical efficacy and safety. Biosimilars are priced 15-75% lower than their reference product, which makes them a less costly alternative and is expected to offer better patients access to biologicals. The total projected cost savings are significant. If the achieved budget savings were used to cover more biological therapy, several additional IBD patients could be treated. Currently, the main barriers to the increasing uptake of biosimilars are the few incentives of the key stakeholders, while physicians’ and patients’ skepticism towards biosimilars seems to be changing. Over the coming years, biosimilars are expected to gain a growing importance in the treatment of IBD, contributing to a better access to treatment, improving population-level health gain and sustainability of health systems. This review summarizes the results of the literature on the economic considerations of biosimilars in IBD and the role of biosimilar infliximab in the treatment of IBD.

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History of Inflammatory Bowel Diseases

Journal of Clinical Medicine ◽

10.3390/jcm8111970 ◽

2019 ◽

Vol 8 (11) ◽

pp. 1970 ◽

Cited By ~ 15

Author(s):

Giovanni Clemente Actis ◽

Rinaldo Pellicano ◽

Sharmila Fagoonee ◽

Davide Giuseppe Ribaldone

Keyword(s):

20Th Century ◽

Inflammatory Bowel Diseases ◽

Intestinal Tuberculosis ◽

Unknown Etiology ◽

Biological Drugs ◽

Bowel Diseases ◽

Inflammatory Bowel ◽

Novel Strategy ◽

Definition Of ◽

Therapeutic Research

Inflammatory bowel diseases (IBD) are characterized by chronic inflammation of the intestinal mucosa and unknown etiology. In this review, we identified three main eras in the IBD history. Between the 19th and the 20th century, the primary task had been the definition of the diagnostic criteria in order to differentiate the new entity from intestinal tuberculosis. In the 20th century, an intense and prolific therapeutic research prevailed, culminating in the introduction of biological drugs in the clinical setting. Since the beginning of the 21st century, traditional definition criteria have been challenged by holistic criteria in an effort to seek a still unattained cure. Centuries of worldwide efforts on IBD etiology and therapy search have culminated in this novel strategy.

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Management of Musculoskeletal Manifestations in Inflammatory Bowel Disease

Gastroenterology Research and Practice ◽

10.1155/2015/387891 ◽

2015 ◽

Vol 2015 ◽

pp. 1-11 ◽

Cited By ~ 8

Author(s):

Tejas Sheth ◽

C. S. Pitchumoni ◽

Kiron M. Das

Keyword(s):

Inflammatory Bowel Diseases ◽

Multidisciplinary Approach ◽

Physical Therapist ◽

Cost Savings ◽

The Past ◽

The Us ◽

Bowel Diseases ◽

Musculoskeletal Manifestations ◽

Inflammatory Bowel ◽

Near Future

Musculoskeletal manifestations are the most common extraintestinal manifestations in inflammatory bowel diseases. Some appendicular manifestations are independent of gut inflammation and are treated with standard anti-inflammatory strategies. On the other hand, axial involvement is linked to gut inflammatory activity; hence, there is a considerable amount of treatment overlap. Biological therapies have revolutionized management of inflammatory bowel diseases as well as of associated articular manifestations. Newer mechanisms driving gut associated arthropathy have surfaced in the past decade and have enhanced our interests in novel treatment targets. Introduction of biosimilar molecules is expected in the US market in the near future and will provide an opportunity for considerable cost savings on healthcare. A multidisciplinary approach involving a gastroenterologist, rheumatologist, and physical therapist is ideal for these patients.

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Metallothioneins in Inflammatory Bowel Diseases: Importance in Pathogenesis and Potential Therapy Target

Canadian Journal of Gastroenterology and Hepatology ◽

10.1155/2021/6665697 ◽

2021 ◽

Vol 2021 ◽

pp. 1-9

Author(s):

Anna Socha-Banasiak ◽

Patrycja Sputa-Grzegrzółka ◽

Jędrzej Grzegrzółka ◽

Krzysztof Pacześ ◽

Piotr Dzięgiel ◽

...

Keyword(s):

Oxidative Stress ◽

Inflammatory Bowel Diseases ◽

Low Molecular Weight ◽

Biological Drugs ◽

Development Of Resistance ◽

Bowel Diseases ◽

Inflammatory Bowel ◽

Therapy Target ◽

Low Molecular Weight Proteins

Immunological disorders, increased oxidative stress, and damage to the epithelial barrier play an important role in the pathogenesis of inflammatory bowel diseases (IBDs). In the treatment of patients with Crohn’s disease (CD) and ulcerative colitis (UC), it is increasingly common to use biological drugs that selectively affect individual components of the inflammatory cascade. However, administering the medicines currently available does not always result in obtaining and maintaining remission, and it may also lead to the development of resistance to a given agent over time. Metallothioneins (MTs) belong to the group of low molecular weight proteins, which, among others, regulate the inflammation and homeostasis of heavy metals as well as participating in the regulation of the intensity of oxidative stress. The results of the studies conducted so far do not clearly indicate the role of MTs in the process of inflammation in patients with IBD. However, there are reports that suggest the possibility of using MTs as a potential target in the treatment of this group of patients.

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Personalized medicine in the treatment of inflammatory bowel diseases

Terapevticheskii arkhiv ◽

10.26442/terarkh20189024-11 ◽

2018 ◽

Vol 90 (2) ◽

pp. 4-11

Author(s):

A I Parfenov ◽

O V Knyazev ◽

A V Kagramanova ◽

N A Fadeeva

Keyword(s):

Personalized Medicine ◽

Inflammatory Bowel Diseases ◽

Clinical Laboratory ◽

Pathological Condition ◽

Individualized Medicine ◽

Individual Characteristics ◽

Phenotypic Traits ◽

Biological Drugs ◽

Bowel Diseases ◽

Inflammatory Bowel

Personalized medicine (personalized medicine, individualized medicine) represents the totality of methods of prevention of a pathological condition, diagnosis and treatment in the event of its occurrence, based on individual patient characteristics. Such individual characteristics include genetic, epigenetic, and transcript, proteome, metabolomic and metagenomic markers, as well as a set of variable phenotypic traits - both of the patient's body and its separate tissues or cells. For example, treatment of inflammatory bowel diseases (IBD) can most clearly show the importance of applying personalized approaches. Currently in the treatment of patients with IBD paid great attention to genetic studies, monitoring of the concentration of the biological drugs and the level of antibodies to them, the role of microbiota as a predictor of effectiveness of therapy of IBD. Used clinical, laboratory, instrumental methods, as well as new biomarkers to assess the forecasting efficiency of conservative therapy in IBD patient. In the future treatment of patients with IBD will include a number of personalized data in order to better predict outcomes of the disease in each patient and more accurately select the appropriate treatment regimen.

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Efficacy, Safety and Immunogenicity of Biosimilars in Inflammatory Bowel Diseases: A Systematic Review

Current Medicinal Chemistry ◽

10.2174/0929867323666161014153346 ◽

2019 ◽

Vol 26 (2) ◽

pp. 270-279 ◽

Cited By ~ 13

Author(s):

Laura Martelli ◽

Laurent Peyrin-Biroulet

Keyword(s):

Inflammatory Bowel Diseases ◽

Patent Protection ◽

Real Life ◽

Cost Savings ◽

High Price ◽

Real World Evidence ◽

Real Life Setting ◽

Bowel Diseases ◽

Post Marketing ◽

Inflammatory Bowel

Background: Anti-tumor necrosis factor (anti-TNF) monoclonal antibodies have revolutionized the treatment of inflammatory bowel diseases (IBD). However, because of their complexity, their production is expensive contributing to their high price. As the patent protection of these therapies has expired in several countries, biosimilars have been developed to reduce the healthcare costs. The aim of this article is to review the literature on the safety, efficacy and immunogenicity of biosimilars in IBD. Methods: A PubMed literature search was performed using the following terms until May 2016: ‘biosimilars’, ‘CT-P13’, ‘infliximab’, ‘Crohn’s disease’, ‘ulcerative colitis’, ‘inflammatory bowel diseases’, ‘efficacy’, ‘safety’, ‘immunogenicity’. Additionally, abstracts from international meetings were also reviewed. Results: A total of eleven studies in IBD patients provided real-world evidence on the efficacy, safety and immunogenicity profile of biosimilars in IBD patients. Based on the available evidence, CT-P13 is efficacious and well tolerated in IBD patients in a real-life setting. The vast majority of studies only included IBD patients who had never received biological therapies. Information regarding the interchangeability between CT-P13 and its originator is currently being investigated in the NOR-SWITCH trial. Otherwise, the immunogenicity profile of CT-P13 seems to be similar to the originator. Conclusion: The infliximab biosimilar seems to be efficacious, safe and with a similar immunogenicity profile as the originator in IBD. Large prospective post-marketing studies are needed to assess the long-term safety profile of CT-P13. The use of infliximab biosimilars may lead to major healthcare cost savings.

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P338 effectiveness and safety of biological therapies in elderly inflammatory bowel diseases patients results from a multi center study of Geteccu

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.462 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S363-S364

Author(s):

C J Suarez Ferrer ◽

F Mesonero ◽

B Caballol ◽

R Saiz Chumillas ◽

I Bastón-Rey ◽

...

Keyword(s):

Elderly Patients ◽

Inflammatory Bowel Diseases ◽

Clinical Remission ◽

Biological Treatment ◽

Moderate Activity ◽

Biological Drugs ◽

Bowel Diseases ◽

Inflammatory Bowel ◽

Multi Center Study

Abstract Background Biological drugs are being increasingly used for the treatment of inflammatory bowel diseases (IBD) in elderly patients. Despite the particular characteristics of this population subgroup, the efficacy and safety of these treatments in real clinical practice is poorly evaluated. Methods Retrospective and multicenter study of GETECCU, carried out in 28 Spanish hospitals. Patients with IBD who started biological treatment (Infliximab, Adalimumab, Golimumab, Ustekinumab or Vedolizumab) aged 65 years or older were included. Efficacy (clinical- at the criteria of the responsible physician-, biochemical and endoscopic) was assessed at 12-14 weeks and at 52 weeks of treatment. Adverse effects such as tumors or serious infections were also recorded. Results A total of 570 patients were included, baseline characteristics are shown in Table 1. Biologics used were: Infliximab (214, 37.5%), Adalimumab (167, 29.3%), Golimumab (16, 2.8%), Ustekinumab (73, 12.8%) and Vedolizumab (100, 17.5%). After 12-14 weeks of treatment, in 38.7% (220) of the cases clinical remission had been achieved and in 47.7% (270) there was clinical response without remission. However, 80 patients (13.9%) had no response, resulting in treatment discontinuation due to primary failure. At week 52, only 379 patients (66.5%) continued on biological treatment: 216 (57%) were in clinical remission (216, 57.0%) while 129 (34%) had response without remission and 34 (9%)had no response. In addition, 119 patients (21%) had an endoscopic study performed: 47 (39,5%) presented with endoscopic remission, 38 (31,9%) with mild activity, 28 (23,5%) with moderate activity and 6, (5.1%) with severe activity. At the end of the follow-up, only 60% of the patients continued on biological treatment, being the reason for withdraw lack of efficacy or due to the report of adverse side effects. Regarding treatment safety in this population, 12.1% (68 patients) suffered an infectious complication with a microbiological diagnosis, requiring hospitalization in 62.1% of the cases. In addition, 39 patients (6.9%) were diagnosed with a tumor until the end of the follow-up, noting that 34.2% of the cases continued on biological therapy after the diagnosis. Likewise, in 25 patients (36.8%) this infection forced discontinuation of biological treatment. Finally, 10 patients stopped biological treatment due to a serious adverse reaction to it Conclusion Response rates to biological treatment in elderly patients are similar to those described in the general population, with approximately one third of failures happening during the first year. However, a remarkable proportion of patients developed a serious adverse effect that could be related to treatment

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