Interchangeable biosimilars: A new era in healthcare system

G. Ramya Balaprabha *, Sindhu Kondapalli, Lahari Pochampally, Tarun Agastya Reddy and T. Rama Rao.

Department of Pharm. D, CMR College Of Pharmacy, India.
 
Review
International Journal of Science and Research Archive, 2024, 13(02), 3763-3773.
Article DOI: 10.30574/ijsra.2024.13.2.2342
Publication history: 
Received on 10 November 2024; revised on 18 December 2024; accepted on 20 December 2024
 
Abstract: 
An important development in the area of biologic drugs, interchangeable biosimilars have possible advantages in terms of accessibility and affordability. Like generic medications are handled, these items are described as biosimilars that can be replaced for the reference biologic without the necessity of physician involvement. To earn this interchangeable designation, the U.S. Food and Drug Administration (FDA) has set particular criteria for a biosimilar which include proving that it is highly similar to the reference product, producing the same clinical outcome in any patient, and ensuring that switching between the two does not pose greater risks than using the reference product alone. Exchangeability requires robust clinical studies, especially those that evaluate the safety and effectiveness of switching biosimilars and reference counterparts. The "three-switch" concept involves patients switching between the reference medicine and the interchangeable biosimilar numerous times. Despite these strict restrictions, interchangeable biosimilars' reduced prices might improve patient access to key biologics, particularly for chronic disorders like autoimmune diseases and malignancies. However, issues exist regarding provider and patient acceptability of these solutions. Concerns over safety, effectiveness, and the ramifications of switching have contributed to reticence in their acceptance. This is especially obvious in therapeutic areas when patients remain stable on their existing therapy. Regulatory frameworks at both federal and state levels also impact how interchangeable biosimilars are employed in reality, with various legislation altering replacement procedures.
In summary, although interchangeable biosimilars have potential for improving healthcare cost and accessibility, continued efforts are required to resolve concerns around their usage and to speed regulatory procedures to ease their adoption in clinical settings.
 
Keywords: 
Biologics; Biosimilars; Interchangeable; Substitution
 
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