Genomics, Biotech, and Emerging Medical Technologies

Overcoming Challenges in the Emerging Biosimilar Landscape (2017 Spring Forum)

A biosimilar is a biologic drug that is developed to be highly similar, but not identical, to an existing biologic. The FDA looks at biosimilars as a biological product that is similar to a US 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. 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. Now, with patents continuing to expire on these first biologics, biosimilar products are becoming available. These agents are expected to have a significant impact on healthcare but present a unique set of challenges for regulators, clinicians, payers, and consumers.
Physician, Nursing and CMCN credits valid to August 1, 2018

Overcoming Challenges in the Emerging Biosimilar Landscape (2016 Fall Forum)

Biologic agents have revolutionized the treatment of many diseases, including cancer, diabetes, hepatitis, inflammatory bowel disease, and rheumatoid arthritis. A biosimilar is a biologic drug that is developed to be highly similar, but not identical, to an existing biologic. Although there are minor differences in clinically inactive components, they cannot have a clinically meaningful difference between the biological product and the reference product in terms of the safety, efficacy and potency. Along with their sensitivity and size, biologic medicines are almost always injected into a patient’s body and the way a patient responses to that treatment can depend on how a biologic is made. Since the complexity of biologic medicines is well documented along with their complex production, biosimilars must be determined on the basis of analytical, non-clinical and clinical data to be similar to an original biologic in structural characteristics, safety and efficacy. Small differences with the active ingredient are expected and permitted so long as any such differences are demonstrated not to be clinically meaningful. Now, with patents continuing to expire on these first biologics, biosimilar products are becoming available. These agents are expected to have a significant impact on healthcare but present a unique set of challenges for regulators, clinicians, payers, and consumers.
Physician, Nursing and CMCN credits valid to January 31, 2018

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