The growing role of biologics and biosimilars in the United States: Perspectives from the APhA Biologics and Biosimilars Stakeholder Conference

Crespi-Lofton, Judy; Skelton, Jann B.

doi:10.1016/j.japh.2017.05.014

Cited by 26 publications

(20 citation statements)

References 9 publications

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“…The European Medicines Agency requires that a biosimilar show “similarity to the reference biologic with respect to quality, biologic activity, safety, and efficacy” [ 8 ]. Biosimilars may expand patient access to bDMARDs because of potentially lower drug prices as a result of price competition within the product market, resulting in savings for health-care systems and patients [ 9 – 11 ].…”

Section: Introductionmentioning

confidence: 99%

A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis

et al. 2018

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BackgroundThis double-blind, randomized, 78-week study evaluated the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of PF-06410293, a candidate adalimumab biosimilar, versus adalimumab reference product (Humira®) sourced from the EU (adalimumab-EU) in biologic-naïve patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) (10–25 mg/week). We report results for the first 26 weeks of treatment.MethodsPatients with active RA (N = 597) were randomly assigned (1:1) to PF-06410293 or adalimumab-EU, while continuing with MTX treatment. The primary endpoint was American College of Rheumatology 20% improvement (ACR20) at week 12. Therapeutic equivalence was concluded if the two-sided 95% confidence interval (CI) for the ACR20 difference between the two arms was entirely contained within the symmetric equivalence margin (±14%). Additionally, a two-sided 90% CI was calculated by using an asymmetric equivalence margin (−12%, 15%). Secondary efficacy endpoints to week 26 included ACR20/50/70, change from baseline Disease Activity Score based on high-sensitivity C-reactive protein [DAS28–4(CRP)], European League Against Rheumatism (EULAR) response, DAS28–4(CRP) of less than 2.6, and ACR/EULAR remission. QuantiFERON-TB testing was performed at screening and week 26.ResultsPatients (78.7% of whom were female and whose mean age was 52.5 years) had a mean baseline RA duration of 6.8 years. The mean baseline DAS28–4(CRP) values were 5.9 (PF-06410293) and 6.1 (adalimumab-EU). The observed week-12 ACR20 values were 68.7% (PF-06410293) and 72.7% (adalimumab-EU) in the intention-to-treat population. With non-responder imputation, the treatment difference in week-12 ACR20 was −2.98% and corresponding CIs—95% CI (−10.38%, 4.44%) and 90% CI (−9.25%, 3.28%)—were entirely contained within the equivalence margins (symmetric and asymmetric, respectively). The secondary efficacy endpoints were similar between arms. Over 26 weeks, injection-site reactions occurred in 1.7% versus 2.0%, hypersensitivity events in 4.4% versus 8.4%, pneumonia in 0.7% versus 2.0%, and opportunistic infections in 2.4% versus 1.7% in the PF-06410293 and adalimumab-EU arms, respectively. One death due to myocardial infarction occurred (adalimumab-EU arm). Rates of anti-drug antibody incidence were 44.4% (PF-06410293) and 50.5% (adalimumab-EU).ConclusionsThe study results demonstrate that efficacy, safety, and immunogenicity of PF-06410293 and adalimumab-EU were similar during the first 26 weeks of treatment in patients with active RA on background MTX.Trial registrationClinicalTrials.gov Identifier: NCT02480153. First posted on June 24, 2015; EU Clinical Trials Register EudraCT number: 2014-000352-29. Start date: October 27, 2014.Electronic supplementary materialThe online version of this article (10.1186/s13075-018-1676-y) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis

et al. 2018

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“…Biosimilar education should be incorporated into curricula of all medical, nursing, and pharmacy schools [ 64 ].…”

Section: Steps To Overcome Biosimilar Disparagement and Misinformatiomentioning

confidence: 99%

The Importance of Countering Biosimilar Disparagement and Misinformation

Cohen¹,

McCabe

2020

BioDrugs

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Biosimilar use is limited in some healthcare systems because biosimilars are not well understood by many healthcare professionals and patients. The knowledge gap is exacerbated by disparagement of biosimilars and dissemination of misinformation, whether intentional or otherwise. There are several different types of disparagement and misinformation directed towards biosimilars as a class, including statements about biosimilar science or policy that are factually incorrect; misleading information, where the information is correct, but is provided out of context; incomplete information, where only partial or a limited set of facts are provided; creation of a false narrative, especially in scientific and medical literature, that provides a set of references to support incorrect conclusions; and negative message framing of factual statements to create a negative perception. Disparagement and misinformation about biosimilars can be countered by educational efforts, appropriate oversight, and regulatory activities with the option of enforcement action by governmental agencies, if warranted. Balanced educational materials about biosimilars should be made easily accessible. Physicians, nurses, pharmacists, and patient advocacy groups should work together to provide patients with consistent, positive messages about the value of biosimilars.

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“…As several studies have identified, the perception and knowledge that health care providers have about biosimilars can influence biosimilar uptake. 5,[11][12][13] In 1 Belgian survey conducted in 2016, about 60% of rheumatologists stated that they believe there are differences in quality,…”

Section: Nicholas Sosulskimentioning

confidence: 99%

A brief overview of biosimilars and factors limiting their uptake

Sosulski¹

2019

Can Pharm J

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The growing role of biologics and biosimilars in the United States: Perspectives from the APhA Biologics and Biosimilars Stakeholder Conference

Cited by 26 publications

References 9 publications

A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis

A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis

The Importance of Countering Biosimilar Disparagement and Misinformation

A brief overview of biosimilars and factors limiting their uptake

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