Abstract
A biosimilar is a biochemical product like another already approved biologic agent, known as the reference agent. To be endorsed by the Food and Drug Administration (FDA), biosimilars must demonstrate that they are as safe and effective as their reference item, with no clinical distinction. Humanized monoclonal antibodies (mAb) are revolutionizing the treatment of gastrointestinal and gynecologic malignancies. Bevacizumab, trastuzumab, cetuximab, rituximab, and pegfilgrastim are the most widely used mAb products with oncologic indications. Due to the complexities of the regulatory system, it may take time for anti-cancer biosimilars to play a significant game-changing role. Over the last decade, the use of generics has saved billions of dollars every year, and it is expected that biosimilars will soon prove to be a cost-effective alternative and can play an important role in driving down healthcare costs globally.In this review, we provide a critical appraisal of biosimilars with an emphasis on bevacizumab-awwb (Avastin) and its clinico-pharmacologic characteristics, safety, efficacy, interchangeability, regulatory and oncologic perspectives, and overall clinical perception.
Highlights
BackgroundA biosimilar is a biochemical with a composition similar to a reference biologic agent and is approved for use in the United States (U.S.) by the Food and Drug Administration (FDA) [1]
We provide a critical appraisal of biosimilars with an emphasis on bevacizumab-awwb (Avastin) and its clinico-pharmacologic characteristics, safety, efficacy, interchangeability, regulatory and oncologic perspectives, and overall clinical perception
A total of 16 biosimilars are available in the European market and many more are reported to be under process
Summary
A biosimilar is a biochemical with a composition similar to a reference biologic agent and is approved for use in the United States (U.S.) by the Food and Drug Administration (FDA) [1]. Similar outcomes are reported between ABP-125 and the bevacizumab reference product in the treatment of advanced non-small-cell lung cancer in a phase III trial (the MAPLE study), conducted in Canada from 2015-2018 [23]. This randomized, double-blind, phase III comparative trial showed a response rate risk ratio of 0.93 with a 90% confidence interval (CI) between 0.80-1.09, which was similar for both Avastin and bevacizumab ABP-125 meeting the primary endpoint [23]. For biosimilars to cause significant flattening of the cost-expenditure curve, strong acknowledgment of their efficacy is needed by oncologists and their patients globally
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