抄録
Biosimilars have emerged as one of the fastest-growing development opportunities in the biopharmaceutical sector. However, biosimilar development presents challenges at every level, from selection of a manufacturing platform, to analytical assays, demonstrating comparability, to in vivo testing, clinical testing, market access, and post-marketing surveillance.
While the opportunity is immense, the risk involved with biosimilar development is still relatively high with large up-front investment required and possible failure of the drug during development stages. Biosimilars are molecules manufactured to emulate a marketed biologic drug in chemical composition and structure, and possess comparable pharmacologic activity, safety and efficacy. Unlike generic small molecule drugs, however, creating an exact copy of a therapeutic protein is impossible, as the manufacturing process is integral to the final drug product composition and by its nature can never be identical. As a result, regulatory agencies evaluate this category of biologics based on their level of similarity to, rather than the exact replication of, the innovator drug.
This poster will present some of the challenges encountered during the development of a biosimilar compound and will highlight the critical factors encountered. Case studies will be presented that illustrate why a particular factor is critical and what the implication was of not paying sufficient attention to this factor.
