Comparative Nonclinical Assessments of the Proposed Biosimilar PF-05280586 and Rituximab (MabThera®)

Ryan, Anne; Sokolowski, Sharon; Ng, Chee-Keng; Shirai, Norimitsu; Collinge, Mark; Shen, A. C.-Y.; Arrington, Joshua; Radi, Smaail; Cummings, Thomas; Ploch, Stephen A.; Stephenson, Sarah; Tripathi, Niraj; Hurst, Susan; Finch, Gregory L.; Leach, Michael W.

doi:10.1177/0192623313520351

Cited by 41 publications

(31 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Three animal studies were assessed using SYRCLE’s risk of bias tool (Supplementary Fig. S6) [24, 29, 34]. The three studies were of moderate quality.…”

Section: Resultsmentioning

confidence: 99%

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence

Jacobs

Ewesuedo

Lula³

et al. 2017

BioDrugs

View full text Add to dashboard Cite

BackgroundBiologic treatments for cancer continue to place a significant economic burden on healthcare stakeholders. Biosimilar therapies may help reduce this burden through cost savings, thereby increasing patient access.ObjectivesThe purpose of this study was to collate all published data to assess the weight of available evidence (quantity and quality) for proposed monoclonal antibody biosimilars and intended copies, for the treatment of cancer.MethodsMEDLINE®, Embase®, and ISI Web of Science® databases were searched to September 2015. Conference proceedings (17) were searched (2012 to July 2015). Searches of the United States National Library of Medicine ClinicalTrials.gov registry were also conducted. Risk of bias assessments were undertaken to assess data strength and validity.ResultsProposed biosimilars were identified in 23 studies (36 publications) in oncology and ten studies in 14 publications in oncology and chronic inflammatory diseases for bevacizumab, rituximab, and trastuzumab originators. Based on our review of the included published studies, and as inferred from the conclusions of study authors, the identified proposed biosimilars exhibit close similarity to their originators. Published data were also retrieved on intended copies of rituximab. It remains unclear what role these agents may have, as publications on rigorous clinical studies are lacking for these molecules.ConclusionWhile biosimilar products have the potential to improve patient access to important biologic therapies, robust evidence of outcomes for monoclonal antibody biosimilars in treating cancer patients, including data from comparative efficacy and safety trials, is not yet available in the published literature. Significant data gaps exist, particularly for intended copies, which reinforces the need to maintain a clear differentiation between these molecules and true biosimilars. As more biosimilars become available for use, it will be important for stakeholders to understand fully the robustness of overall evidence used to demonstrate biosimilarity and gain regulatory approval.Electronic supplementary materialThe online version of this article (doi:10.1007/s40259-016-0207-0) contains supplementary material, which is available to authorized users.

show abstract

“…Three animal studies were assessed using SYRCLE’s risk of bias tool (Supplementary Fig. S6) [24, 29, 34]. The three studies were of moderate quality.…”

Section: Resultsmentioning

confidence: 99%

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence

Jacobs

Ewesuedo

Lula³

et al. 2017

BioDrugs

View full text Add to dashboard Cite

show abstract

“…Drug Discovery Today Volume 20, Number 4 April 2015 nonresponsive rat repeat-dose toxicity study. By contrast, nonhuman primates have been extensively used to assess the biosimilarity of some rituximab biosimilars [41,42]. In the EU, studies in nonhuman primates might no longer be required, given the new overarching draft guidance for biosimilar development, in which the limited relevance of animal studies is acknowledged [43].…”

Section: Reviewsmentioning

confidence: 99%

Contribution of animal studies to evaluate the similarity of biosimilars to reference products

Meer

Ebbers

Kooijman

et al. 2015

Drug Discovery Today

View full text Add to dashboard Cite

The European Union (EU) was the first region to establish a regulatory framework for biosimilars, in which animal studies are required to confirm similarity to a reference product. However, animal studies described in European public assessment reports (EPARs) or marketing authorization applications (MAAs) did not identify clinically or toxicologically relevant differences despite differences in quality, suggesting that animal studies lack the sensitivity to confirm biosimilarity. Scientific advice provided learning opportunities to evolve existing guidance. Altogether, the data support a step-wise approach to develop biosimilars that focuses on quality and clinical efficacy of biosimilar. This approach might be more effective and does not necessarily require animal studies, which is also reflected in new EU draft guidance.

show abstract

“…The majority of studies published as conference abstracts were of good or excellent quality (81.8%). Three animal studies were assessed using SYRCLE’s risk of bias tools [49, 51, 84] and found to be of moderate quality (ESM Fig. S4).…”

Section: Resultsmentioning

confidence: 99%

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

et al. 2016

Self Cite

View full text Add to dashboard Cite

BackgroundDespite regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and the data that underpin it.ObjectivesThe objectives of the study were to systematically collate published data for monoclonal antibodies and fusion protein biosimilars indicated for cancer, chronic inflammatory diseases, and other indications, and to explore differences in the type and weight (quantity and quality) of available evidence.MethodsMEDLINE, Embase, and ISI Web of Science were searched to September 2015. Conference proceedings (n = 17) were searched 2012 to July 2015. Included studies were categorized by originator, study type, and indication. To assess data strength and validity, risk of bias assessments were undertaken.ResultsAcross therapeutic areas, 43 named (marketed or proposed) biosimilars were identified for adalimumab, abciximab, bevacizumab, etanercept, infliximab, omalizumab, ranibizumab, rituximab, and trastuzumab originators. Infliximab CT-P13, SB2, and etanercept SB4 biosimilars have the greatest amount of published evidence of similarity with their originators, based on results of clinical studies involving larger numbers of patients or healthy subjects (N = 1405, 743, and 734, respectively). Published data were also retrieved for marketed intended copies of etanercept and rituximab.ConclusionsThis unbiased synthesis of the literature exposed significant differences in the extent of published evidence between molecules at preclinical, clinical, and post-marketing stages of development, providing clinicians and payers with a consolidated view of the available data and remaining gaps.Electronic supplementary materialThe online version of this article (doi:10.1007/s40259-016-0199-9) contains supplementary material, which is available to authorized users.

show abstract

Comparative Nonclinical Assessments of the Proposed Biosimilar PF-05280586 and Rituximab (MabThera®)

Cited by 41 publications

References 15 publications

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence

Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence

Contribution of animal studies to evaluate the similarity of biosimilars to reference products

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence

Contact Info

Product

Resources

About