Biosimilars as a Future, Promising Solution for Financial Toxicity: A Review with Emphasis on Bevacizumab

被引:9
|
作者
Saleem, Tabinda [1 ]
Qurashi, Hafiz [1 ]
Jamali, Munira [2 ]
Gomez, Janet Chan [1 ]
Kanderi, Tejaswi [1 ]
机构
[1] Univ Pittsburgh Med Ctr UPMC Pinnacle, Internal Med, Harrisburg, PA 17104 USA
[2] Dow Univ Hlth Sci DUHS, Dow Med Coll, Internal Med, Karachi, Pakistan
关键词
biosimilars; oncologic application; bevacizumab; cost effective therapy; commercialization; global oncology costs; PHARMACOKINETICS; EFFICACY; SAFETY;
D O I
10.7759/cureus.9300
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 bevacizumabawwb (Avastin) and its clinico-pharmacologic characteristics, safety, efficacy, interchangeability, regulatory and oncologic perspectives, and overall clinical perception.
引用
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页数:10
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