什么是生物药和生物类似药?
It is likely you have heard the terms biological or biosimilar drugs and wondered, 这到底是什么意思?” Or you may have heard of many of these drugs not realizing they are biologicals or biosimilars. 例如, 抗, Enbrel和Stelara, 如果你经常看电视的话, it is likely you have seen a commercial for one of these and, 是的, 这些是生物药物. In this article we will discuss what biological and biosimilar drugs are, 是什么让它们与传统药物不同呢, 具体的例子与工人的补偿.
生物药物, 也被称为生物制剂, are pharmaceutical products derived from natural systems such as human, 动物或微生物及, 根据美国.S. 食物及药物管理局(食品及药物管理局), may be produced by biotechnology methods and other technologies. 生物制剂可以由细胞组成, 组织, 蛋白质, 糖, 核酸, or a combination of these making them highly complex in structure and requiring highly specialized manufacturing processes. This contrasts with conventional drugs that are, for the most part, chemically synthesized in a lab.
Many biological drugs also have strict storage requirements and may lose efficacy quickly if not stored properly. Conventional drugs have more forgiving storage requirements and remain stable for longer periods of time. Some examples of biological drugs that may be seen in work comp are Botox for migraines, 治疗哮喘的Xolair或治疗贫血的Procrit. 生物制剂 may not be seen in workers' comp as often as conventional drugs, but when they do show up it is noticeable because of the high cost. One reason for the sustained high cost of biologics is because many are still the original innovator product, 或参考产品, and there is no competition in the market to bring the price down. 这就是生物仿制药的用武之地.
The 食品及药物管理局 definition of a biosimilar medication is “a biological product that is highly similar to and has no clinically meaningful differences in terms of safety or effectiveness from an existing 食品及药物管理局-licensed (approved) reference product.“一旦生物仿制药被食品及药物管理局批准, the increased market competition helps bring the cost down. One additional layer to this is something called interchangeable biological products. These biological products have met additional requirements allowing them to be substituted for the original reference product at the pharmacy without the prescriber having to rewrite the prescription. 生物制剂 and any approved biosimilars or interchangeable biosimilars can be found online at http://purplebooksearch.FDA.gov/.
参考产品就是一个例子 应用. If the prescriber writes a prescription for 应用 the pharmacy may substitute for Rezvoglar or Semglee without having the prescription re-written since they are interchangeable biosimilars to the reference product. One way to think of it is, interchangeable biosimilars are to biologics as generics are to brands. 值得注意的是, 然而, that the standards and requirements to become an 食品及药物管理局-approved interchangeable biosimilar are different from becoming an 食品及药物管理局-approved generic. Many new biologics and biosimilars are likely to hit the market in coming years as advances in biomedical technology continue. The medical community is hopeful that previously untreatable conditions and complex illnesses will have treatment options made possible by biological drugs in the future.
此信息旨在作为总体概述, and any specific questions or concerns should be more fully reviewed with your health care professional such as the prescribing doctor or dispensing pharmacist.
Do you have a workers’ compensation or auto related pharmacy question? 给我们发邮件 AskThePharmacist@米切尔.com.
要阅读更多的问药剂师文章，请访问 米切尔.com/ask-the-pharmacist.