Biosimilars: concept, current status, and future perspectives in inflammatory bowel diseases

Park, Sang Hyoung; Park, Jae Cheol; Lukáš, Milan; Kolář, Martin; Loftus, Edward V.

doi:10.5217/ir.2019.09147

Cited by 21 publications

(19 citation statements)

References 59 publications

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“…have improved patient access to biologic therapy (4,5) and resulted in price reductions for reference biologics (6,7).…”

Section: Accepted Articlementioning

confidence: 99%

“…access to biologic therapy 4,5 and resulted in price reductions for reference biologics. 6,7 The determination of biosimilarity by regulators, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), is based on the "totality of evidence" from a stepwise comparative similarity exercise (including analytical analyses, nonclinical studies, and clinical trials) between the proposed biosimilar and its reference product.…”

Section: How Might This Change Clinical Pharmacology or Translational Science?mentioning

confidence: 99%

“…1 , 2 , 3 In the United States and Europe, reference adalimumab is also approved for the treatment of juvenile idiopathic arthritis, ankylosing spondylitis (in adults), psoriatic arthritis (in adults), psoriasis (for the United States, only adults), hidradenitis suppurativa, Crohn’s disease, ulcerative colitis (in adults), uveitis, and nonradiographic axial spondyloarthritis (in adults; Europe only). 1 , 2 Although high costs of TNF inhibitors, such as adalimumab, may limit access to these medications for patients with these immune‐mediated inflammatory diseases, 4 , 5 lower‐cost biosimilars have improved patient access to biologic therapy 4 , 5 and resulted in price reductions for reference biologics. 6 , 7 …”

Section: Introductionmentioning

confidence: 99%

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Pharmacokinetic equivalence of CT‐P17 to high‐concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects

Jang

Lim

et al. 2021

Clinical Translational Sci

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and European Union-approved adalimumab (EU-adalimumab). This double-blind, parallel-group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/mL) subcutaneous injection of CT-P17, US-adalimumab, or EU-adalimumab. Primary endpoints were PK equivalence in terms of: area under the concentration-time curve from time zero to infinity (AUC 0-inf); area under the concentration-time curve from time zero to the last quantifiable concentration (AUC 0-last); and maximum serum concentration (C max). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (gLSMs) for pairwise comparisons were within the equivalence margin of 80-125%. Additional PK endpoints, safety, and immunogenicity were evaluated. Of the 312 subjects who were

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“…have improved patient access to biologic therapy (4,5) and resulted in price reductions for reference biologics (6,7).…”

Section: Accepted Articlementioning

confidence: 99%

Section: How Might This Change Clinical Pharmacology or Translational Science?mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Pharmacokinetic equivalence of CT‐P17 to high‐concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects

Jang

Lim

et al. 2021

Clinical Translational Sci

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“…Health authorities and insurance companies both share these burdens, which impact personal and societal health. Although the lack of resources could be partially answered by using biosimilars and generics [ 6 ], the overcrowded market of generics continues to be a major challenge for companies. Similarly, the overall response rate to innovative medications for NCDs is far from ideal, leaving high percentages of non-responsive patients and creating an economic burden for healthcare systems.…”

Section: Introductionmentioning

confidence: 99%

Improving Global Healthcare and Reducing Costs Using Second-Generation Artificial Intelligence-Based Digital Pills: A Market Disruptor

Ilan

2021

IJERPH

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Background and Aims: Improving global health requires making current and future drugs more effective and affordable. While healthcare systems around the world are faced with increasing costs, branded and generic drug companies are facing the challenge of creating market differentiators. Two of the problems associated with the partial or complete loss of response to chronic medications are a lack of adherence and compensatory responses to chronic drug administration, which leads to tolerance and loss of effectiveness. Approach and Results: First-generation artificial intelligence (AI) systems do not address these needs and suffer from a low adoption rate by patients and clinicians. Second-generation AI systems are focused on a single subject and on improving patients’ clinical outcomes. The digital pill, which combines a personalized second-generation AI system with a branded or generic drug, improves the patient response to drugs by increasing adherence and overcoming the loss of response to chronic medications. By improving the effectiveness of drugs, the digital pill reduces healthcare costs and increases end-user adoption. The digital pill also provides a market differentiator for branded and generic drug companies. Conclusions: Implementing the use of a digital pill is expected to reduce healthcare costs, providing advantages for all the players in the healthcare system including patients, clinicians, healthcare authorities, insurance companies, and drug manufacturers. The described business model for the digital pill is based on distributing the savings across all stakeholders, thereby enabling improved global health.

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“…Biosimilar infliximab (CT-P13) is a chimeric human-mouse monoclonal antibody against TNF-α. CT-P13 is frequently used as an effective and safe alternative for original infliximab (IFX) [7][8][9][10]. While it is an important drug in IBD treatment, a significant problem may be the primary lack or secondary loss of response (LOR) to therapy.…”

Section: Introductionmentioning

confidence: 99%

Levels of Biosimilar Infliximab during and after Induction Treatment in Crohn’s Disease and Ulcerative Colitis—A Prospective Polish Population Study

Pękala

Filip

2021

JCM

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Background: Primary lack or secondary loss of response to therapy with infliximab is a significant problem. This study aimed to evaluate the response to treatment in patients with Crohn’s disease (CD) and ulcerative colitis (UC) achieving therapeutic and sub-therapeutic trough levels of biosimilar infliximab (CT-P13). Results: A total of 65 patients (32 with CD and 33 with UC) were recruited. The overall response rate in both CD and UC patients exceeded 80%. There were no significant differences in treatment response and CT-P13 levels for patients with CD or UC. We did not find significant differences in the percentage of patients achieving drug levels of 3 μg/mL at week 6, 10, or 12; a significant decrease was observed at week 14. Up to 55.5% of patients with CD and 64.3% of patients with UC with sub-therapeutic CT-P13 levels at week 14 primarily responded to treatment. Conclusions: Intermediate measurements of drug levels at weeks 10 and 12 did not capture any pronounced decrease in infliximab concentrations below therapeutic levels in either group, thus suggesting no clinical usefulness. A significant percentage of patients primarily responded to treatment despite sub-therapeutic drug levels after the induction phase.

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Biosimilars: concept, current status, and future perspectives in inflammatory bowel diseases

Cited by 21 publications

References 59 publications

Pharmacokinetic equivalence of CT‐P17 to high‐concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects

Pharmacokinetic equivalence of CT‐P17 to high‐concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects

Improving Global Healthcare and Reducing Costs Using Second-Generation Artificial Intelligence-Based Digital Pills: A Market Disruptor

Levels of Biosimilar Infliximab during and after Induction Treatment in Crohn’s Disease and Ulcerative Colitis—A Prospective Polish Population Study

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