Abas Arpah
Biotechnology Section, National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Jalan University, Petaling Jaya, Selangor, Malaysia.
Biologicals. 2011 Sep;39(5):339-42. doi: 10.1016/j.biologicals.2011.06.009. Epub 2011 Jul 23.
The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products.
生物类似药领域继续引发巨大的关注和争议。生物类似药是“相似”但并非等同于创新产品的新型生物制药。生物制药的特性与生产工艺密切相关，这意味着产品无法被精确复制。产品结构和生产工艺中的微小差异可能导致不同的临床结果。这引发了对生物类似药的安全性、有效性甚至药物警戒的担忧。因此，生物类似药具有独特性——它们并非真正的化学仿制药，而是通过独特的监管框架进行监管。本报告讨论了马来西亚对生物类似药的监管特点以及在评估来自不同国家的一些产品过程中获得的经验。确保监管立场充分反映科学进展、专业知识/资源是关键。监管情况是一个不断发展的过程。目前正在编写各种指导文件，旨在建立一个统一的全球框架，以实现降低成本和保障患者安全的双重目标，同时加快重要生物类似药产品的上市。
