Biosimilars in Oncology: Latest Trends and Regulatory Status

Abstract

Biologic-based medicines are used to treat a variety of diseases and account for around one-quarter of the worldwide pharmaceutical market. The use of biologic medications among cancer patients has resulted in substantial advancements in cancer treatment and supportive care. Biosimilar medications (or biosimilars) are very similar to the reference biologic drugs, although they are not identical. As patent protection for some of the most extensively used biologics begins to expire, biosimilars have the potential to enhance access and provide lower-cost options for cancer treatment. Initially, regulatory guidelines were set up in Europe in 2003, and the first biosimilar was approved in 2006 in Europe. Many countries, including the United States of America (USA), Canada, and Japan, have adopted Europe’s worldwide regulatory framework. The use of numerous biosimilars in the treatment and supportive care of cancer has been approved and, indeed, the count is set to climb in the future around the world. However, there are many challenges associated with biosimilars, such as cost, immunogenicity, lack of awareness, extrapolation of indications, and interchangeability. The purpose of this review is to provide an insight into biosimilars, which include various options available for oncology, and the associated adverse events. We compare the regulatory guidelines for biosimilars across the world, and also present the latest trends and challenges in medical oncology both now and in the future, which will assist healthcare professionals, payers, and patients in making informed decisions, increasing the acceptance of biosimilars in clinical practice, increasing accessibility, and speeding up the health and economic benefits associated with biosimilars.

Costs to Medicare of Nonrecommended Bone-Modifying Agent Use for Castration-Sensitive Prostate Cancer

“…Drug spending may also be reduced by availability of biosimilar versions of denosumab 19 if biosimilars versions are priced substantially lower and achieve a large market share-neither of which is guaranteed in the context of oncology biosimilars. 20 Our estimate of excess BMA costs for CSPC is intentionally conservative in several aspects. commercially insured patients are likely to be substantially higher on a per-patient basis because providers typically charge substantially greater markups to commercial insurers on provider-administered medications than what is allowed under Medicare.…”

“…Drug spending may also be reduced by availability of biosimilar versions of denosumab 19 if biosimilars versions are priced substantially lower and achieve a large market share—neither of which is guaranteed in the context of oncology biosimilars. 20…”

Cancer treatment with biosimilar drugs: A review

“…The only concerned factor for oncologists switching from original biological products to biosimilars is the loss of efficacy and adverse events while clinical alteration in the biological drugs that can induce immunogenicity. Despite many studies, biosimilars have proven safe and effective not only for the treatment of cancer but also for other diseases such as Crohn's disease, colitis, and so on [72].…”