Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects

Wynne, Christopher; Altendorfer, Mario; Sonderegger, Ivo; Gheyle, Lien; Rb, Ellis-Pegler; Buschke, Susanne; Lang, Benjamin; Assudani, Deepak; Athalye, Sandeep N.; Czeloth, Niklas

doi:10.1080/13543784.2016.1255724

Cited by 57 publications

(61 citation statements)

References 17 publications

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“…Pharmacokinetic data have now been published for several products, (e.g. [23,26]): the results confirm our finding of pharmacokinetic similarity between EUand US-Humira. In September 2016, the US Food and Drug Administration approved Amjevita, a biosimilar to Humira, for multiple inflammatory diseases [27].…”

Section: Tablesupporting

confidence: 88%

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Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects

Puri

Niewiarowski

Arai

et al. 2017

Brit J Clinical Pharma

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Section: Tablesupporting

confidence: 88%

“…However, the quality profile of Humira is well controlled [22]. Several other biosimilars of Humira are in development, most of which have used Humira from the US and EU as reference materials [23][24][25][26]. Pharmacokinetic data have now been published for several products, (e.g.…”

Section: Tablementioning

confidence: 99%

Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects

Puri

Niewiarowski

Arai

et al. 2017

Brit J Clinical Pharma

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“…To our knowledge, no published clinical trials evaluating the approved adalimumab biosimilars ABP 501, BI 695501, or SB5 in IBD, or real-world evidence for other infliximab biosimilars exist. All three adalimumab biosimilars have demonstrated pharmacokinetic similarity to the RP in equivalence studies in healthy subjects [125][126][127] and similar efficacy and safety in clinical trials in patients with RA [128][129][130].…”

Section: Gastroenterologists' Perspective: Earlier Introduction Of Bimentioning

confidence: 94%

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Kim

Alten

Avedano³

et al. 2020

Drugs

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Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars-biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators-can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.

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“…Nevertheless, most clinical trials with currently available biosimilars have been trials with rheumatoid arthritis and ankylosing spondylitis . Table shows the available clinical study data for approved biosimilars as well as other biosimilars that are expected shortly on the market . It is conceivable that rheumatic diseases have been chosen because anti‐TNFα compounds are used more frequently by rheumatologists than by dermatologists.…”

Section: Clinical Studies Required For Biosimilar Approvalmentioning

confidence: 99%

Biosimilars in Dermatology – theory becomes reality

Gerdes

Mrowietz

Augustin

et al. 2018

J Deutsche Derma Gesell

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SummaryBiosimilars are biological medicines that are analogues of a specific reference product. Biosimilars of the tumor necrosis factor alpha inhibitors infliximab and etanercept are already approved and available for dermatological indications. Regulatory agencies require in-depth analysis of physicochemical and functional properties of these highly complex molecules as well as clinical data on their similarity regarding efficacy and safety in at least one clinical trial in a sensitive and homogeneous population. Thus, it must be shown that biosimilars are essentially the same as the originator product if they are to be licensed in regulated drug markets. As a consequence, these data are extrapolated from one molecule (the originator) to another (biosimilar) resulting in an approval that includes the same indications as the originator product. While extrapolation is well accepted and regulated, clear recommendations regarding the interchangeability of originators and biosimilars as well as data on multiple consecutive switching are missing. Current scientific knowledge does not argue against the use of biosimilars for dermatological indications, but sequential switching of biosimilars should be considered carefully. To increase confidence and enhance evidence for biosimilars, accurate documentation of the specific products given to each patient is essential and should preferably be included in patient registries.

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Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects

Abstract: 2013-003722-84 (EudraCT) and NCT02045979.

Cited by 57 publications

References 17 publications

Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects

Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Biosimilars in Dermatology – theory becomes reality

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