TOP - October 2021 Vol 14, No 6 | Biosimilars

The advent of biologic drugs has had a significant impact on the management of patients with cancer. However, the high costs associated with these agents can hinder treatment access for many patients and place a significant burden on healthcare systems.
On September 20, 2021, the FDA announced the availability of its revised final guidance for industry on biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Policymakers are once again focusing attention on proposals to lower prescription drug costs.
As biosimilars are being used more and more in cancer treatment, it is increasingly important that navigators and financial advocates be familiar not only with how they work but also how patients with cancer should go about paying for them, according to Angie Santiago, AA, CRCS-I, lead financial advocate at the Sidney Kimmel Cancer Center/Jefferson Health.
During the 2021 European Society for Medical Oncology virtual meeting, 5-year follow-up data from a clinial trial showed comparable results related to cardiac safety and long-term efficacy between trastuzumab (Herceptin) and the biosimilar trastuzumab-dttb (SB3; Ontruzant) in patients with HER2-positive, early or locally advanced breast cancer.
Results from a phase 3 clinical trial showed equivalence between the bevacizumab biosimilar, BCD-021, and the reference product, bevacizumab (Avastin), in terms of overall response rate (ORR) in patients with stage IIIB or IV nonsquamous non–small-cell lung cancer.
Febrile neutropenia (FN) is a serious side effect of many cancer treatments and can lead to severe infection and sepsis with potentially fatal consequences.
Biosimilars are poised to bring significant cost-savings opportunities in oncology, while maintaining high-quality patient care.
Cancer remains one of the costliest diseases to treat in the United States.
Cancer remains one of the costliest diseases to treat in the United States.
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