Biosimilar products are not bioidentical 生物仿制药品并不一定具有相同的生物学效应
摘要
When the patents on oral medications expire, the development and marketing of the same chemical entity by other manufacturers becomes possible. To market such agents, strict controls on the pharmacokinetics of newer agents are imposed to ensure highly similar, if not identical medication exposure and efficacy, as well as safety, compared to the progenitor drug. In most cases, the use of such so-called generic compounds has resulted in similar outcomes, as experienced with the parent compound. Problems have arisen with the expiration of patents on biological preparations, for which current guidelines for generic oral medications may have little applicability. Until recently, the development and marketing of similar chemical entities of biologics has been treated as new chemical entities, which mandate safety and efficacy trials prior to FDA approval for marketing. This arrangement has not, however, reduced costs for many of these otherwise very expensive biological entities. Since most of these agents are highly complex proteins carried in unique and equally complex vehicles, costs associated with their creation remain rather high. To address these concerns, it has been proposed to identify proteins of equivalent structure as “Biosimilar” and to develop a pathway for approval by the FDA for these new agents similar to that of oral generics. Cost concerns have become a major focus of healthcare delivery systems in recent years. With the increasing availability of unique and highly effective biological products for an ever diverse number of diseases, the expanding use of such products has severely impacted budgets for pharmaceutical products in every major area of medical therapeutics. It is therefore obvious that the perceived need to reduce costs to the healthcare system is the driving force behind the development of the Biosimilar project. Endocrinologists have had extensive experience with biological agents in the form of insulins. This life-saving protein hormone