Genomics, Biotech, and Emerging Medical Technologies
Biosimilars are biologic drugs that are highly similar to drugs developed for various indications and have no meaningful differences in safety, purity and potency. While biosimilars have some differences compared with their reference products, the differences do not affect efficacy, safety, mechanisms of action, condition or approved indications. 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. The goal of biosimilars is to demonstrate biosimilarity between the proposed biosimilar product and the reference product, although not necessarily interchangeable. To be considered interchangeable, biosimilars require evidence that they have the same clinical result as the reference product. An interchangeable product must also demonstrate that there is no greater risk in switching between the two drugs in terms of safety and efficacy. Biosimilars manufacturers limit the number of times that they conduct expensive and lengthy clinical trials, to potentially lead to faster access to these products, additional therapeutic options, and reduced costs for patients. This allows for better data and key analytics when determining if the biosimilar agent is effective and maintains a level of safety and efficacy. Once a biosimilar is approved for use by the FDA, it can be approved for additional indications (conditions) based on a concept called extrapolation of data. If the data collected on the biosimilar in preclinical work shows the same clinical result as the original product, additional clinical trials do not have to be conducted. Given the constant changes in biosimilars, 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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