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Future Scope of Biosimilars for the Treatment of Various Cancers

  • Ashwin Subramanian,
  • Gayathri Devi Muthukumarasamy,
  • Saraswathi Venkataraman,
  • Karthika Rangasamy,
  • Ananya Nitin Kanade,
  • Pavithra Vimala Arulrajan,
  • Keerthana Saravanan,
  • Suhashini Shanmuganathan,
  • Gayathri Gopal,
  • Senthil Visaga Ambi

摘要

Advancements in the identification of molecular drug targets and new therapeutic options for different cancer types have paved the way for target-based therapies for cancer. In this vein, biosimilars have revolutionized the cancer treatment options and have significant clinical outcomes. Because of the development of biologic medications, cancer treatment and supportive care have evolved dramatically. Biologics are increasingly being employed in cancer therapy and palliative care. However, these therapies continue to impose a significant financial burden on healthcare stakeholders. Cancer biologics are advanced treatments derived from the living organisms that are in practice in modern healthcare. But there is a shift towards biosimilars, which is driven by the aim to increase affordability while upholding the same high standards of quality, safety, and effectiveness for these life-saving therapies. The objective of this transition is to provide economically viable alternatives for patients without compromising the fundamental characteristics of these pioneering drugs, which are essential in the treatment of cancer. Biosimilars are found to play an increasingly important role in cancer treatment, assisting in improving access to novel treatment options by lowering costs. Since biosimilars are substantially similar but not identical to reference products, rigorous regulatory procedures have been established for their approval. These regulatory frameworks specify the conditions for biosimilar approval, such as analytical tests comparing the biosimilar to the authorized biologic medicine. To determine the toxicity, efficacy, safety profiles, and pharmacokinetic/pharmacodynamic properties, nonclinical and clinical research are necessary for some of the biosimilars that have been approved by FDA including rituximab, trastuzumab, bevacizumab, filgrastim, pegfilgrastrim, and epoetins. When compared to chemotherapy alone, the addition of monoclonal antibodies such as bevacizumab and trastuzumab to the antineoplastic therapy has helped to significantly improve key outcomes such as progression-free survival (PFS) and overall survival (OS). Trastuzumab, for example, is designed to selectively inhibit the human epidermal growth factor 2 (HER2) receptor, whereas bevacizumab is designed to target vascular endothelial growth factor. Biosimilars not only increase the range of treatment options but also provide a safety net when the reference biologic is in short supply or unsuitable for specific patients. Additionally, the affordability of biosimilars contributes to the long-term sustainability of healthcare systems, especially in the face of the growing demand for cancer treatments. Finally, the development and production of biosimilars foster ongoing research and innovation in the fields of biotechnology and oncology, ultimately leading to improvements in treatment methods and patient outcomes. The development process for a biosimilar differs significantly from that of the original biologic. A better comprehension of the rigorous procedures involved in the development and approval of biosimilar drugs, along with increasing experience in their utilization, should alleviate these concerns. The future of biosimilars involves improved access to vital treatments, more diverse biosimilar choices, regulatory enhancements, and better patient education. These changes can substantially enhance patient results and alleviate the economic strain on healthcare, potentially revolutionizing the pharmaceutical field and boosting healthcare sustainability. This chapter highlights the benefits and challenges surrounding biosimilars in cancer treatment, emphasizing the need for continued research, education, and regulatory advancements to realize their potential.