Enerceptan (etanercept biosimilar)
/ AMEGA Biotech
- LARVOL DELTA
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August 02, 2022
Biosimilars for Chronic Inflammation Management - Episode 2: Difference Between Biosimilars and Reference Product
(Rheumatology Network)
- "Joel M. Gelfand, MD, MSCE, FAAD: They are just that. The reference product is usually the originator biologic, the one that did large-scale pivotal trials, often placebo-controlled or active comparator studies, competitor studies, or some type of standard of care. We've been using a lot of these molecules for decades. For example, etanercept and infliximab were approved in the late 1990s. Then the biosimilar product is a manufactured biologic process that, as you mentioned, doesn't differ chemically or structurally in any important ways from the originator product, and then clinically has demonstrated very similar safety and efficacy."
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