Current state and comparison of the clinical development of bevacizumab, rituximab and trastuzumab biosimilars

Monoclonal antibodies are highly complex, large and biologic products with a substantial impact on the clinical management of a variety of diseases including cancer. The expiry of patents for essential monoclonal antibodies in cancer care such as bevacizumab, rituximab and trastuzumab, has prompted the global development of biosimilars to balance the biologics market. However, an understanding of the different approach of biosimilar development compared with its reference medicinal product, especially in the context of clinical trial design and end point selection may help oncologists integrating biosimilars into clinical practice. Herein, we reviewed the clinical development of biosimilars in oncology comparing the available clinical data of proposed biosimilars of bevacizumab, rituximab and trastuzumab.

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Conceptual Framework to Support Clinical Trial Optimization and End-to-End Enrollment Workflow

JCO Clinical Cancer Informatics ◽

10.1200/cci.19.00033 ◽

2019 ◽

pp. 1-10 ◽

Cited By ~ 3

Author(s):

Neha M. Jain ◽

Alison Culley ◽

Teresa Knoop ◽

Christine Micheel ◽

Travis Osterman ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Knowledge Representation ◽

Conceptual Framework ◽

Trial Design ◽

Clinical Trial Design ◽

Prospective Clinical Trial ◽

Future Trends ◽

Current State ◽

Evaluation Strategies

In this work, we present a conceptual framework to support clinical trial optimization and enrollment workflows and review the current state, limitations, and future trends in this space. This framework includes knowledge representation of clinical trials, clinical trial optimization, clinical trial design, enrollment workflows for prospective clinical trial matching, waitlist management, and, finally, evaluation strategies for assessing improvement.

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Edaravone in Amyotrophic Lateral Sclerosis’Lessons from the Clinical Development Program and the Importance of a Strategic Clinical Trial Design

US Neurology ◽

10.17925/usn.2018.14.1.47 ◽

2018 ◽

Vol 14 (1) ◽

pp. 47 ◽

Cited By ~ 5

Author(s):

Said R Beydoun ◽

Jeffrey Rosenfeld

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Amyotrophic Lateral Sclerosis ◽

Trial Design ◽

Development Program ◽

Clinical Trial Design ◽

Clinical Development ◽

Disease Heterogeneity ◽

Clinical Development Program ◽

Lateral Sclerosis

Edaravone significantly slows progression of amyotrophic lateral sclerosis (ALS), and is the first therapy to receive approval by the Food and Drug Administration (FDA) for the disease in 22 years. Approval of edaravone has marked a new chapter in pharmaceutical development since the key trial included a novel strategic clinical design involving cohort enrichment. In addition, approval was based on clinical trials that had a relatively small patient number and were performed outside of the US. Edaravone was developed through a series of clinical trials in Japan where it was determined that a well-defined subgroup of patients was required to reveal a treatment effect within the study period. Amyotrophic lateral sclerosis is associated with wide-ranging disease heterogeneity (both within the spectrum of ALS phenotypes as well as in the rate of progression). The patient cohort enrichment strategy aimed to address this heterogeneity and should now be considered as a viable, and perhaps preferred, trial design for future studies. Future research incorporating relevant biomarkers may help to better elucidate edaravone’s mechanism of action, pharmacodynamics, and subsequently ALS phenotypes that may preferentially benefit from treatment. In this review, we discuss the edaravone clinical development program, outline the strategic clinical trial design, and highlight important lessons for future trials.

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