Genomics, Biotech, and Emerging Medical Technologies
Biologic agents have revolutionized the treatment of many diseases, including breast cancer, lung cancer, non-Hodgkin’s lymphoma, hepatitis, inflammatory bowel disease (IBD), rheumatoid arthritis, and many more. Biosimilars are expected to have a significant impact on healthcare but present a unique set of challenges for regulators, clinicians, payers, and consumers. The development of new biologics may be a big step in effectively treating diseases for which there are currently no cures. At present, there are biosimilars for filgrastim, infliximab, etanercept, adalimumab, trastuzumab, and bevacizumab. The FDA looks at biosimilars as a biological product that is similar to a U.S. licensed biological product not including minor differences in clinically inactive components, as well as having no clinically meaningful differences between the biological product and the reference product in terms of the safety, efficacy and potency of the product. Recent and upcoming patent expirations for some of the most commonly used biologic agents have led to the development of biosimilar products. Evidence suggests that clinicians need to be continually educated about the multiple aspects of biosimilars, including the underlying scientific principles, the development and regulatory pathways, how to use them in clinical practice, as well as educating their patients about their value.
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