원문정보
초록
영어
Since the market approval of recombinant human insulin as a drug for diabetes treatment in 1982, many recombinant DNA pharmaceutical products including TNF‐alpha blockers have been developed. In general, these products have relatively lower incident of adverse events and high efficacy rates with their targeting properties. As approaching the expiration of patents for the first group of the originator bioproducts, developing “biosimilar” products to be a first provider in the market has been an issue amongst pharmaceutical companies.
However, due to large and complex molecular structure of biologics, manufacturing processes including types of cell lines and media are highly influencing on the product quality. Even when a minuscule modification is applied in the manufacturing process of a biological product, it is hardly assure that the product is the same as the one made through previous process. Therefore, the comparability to original products is an essential component in biosimilar product development.
Comparability is not only an issue of quality but issues carefully treated in safety and efficacy evaluation. In this presentation, we will share the experience gained through the biosimilar development and discuss about potential problems in depth.