School of Medicine Kaohsiung Medical University, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou 1st Road, Kaohsiung, Taiwan.
Curr Rheumatol Rep. 2017 Aug;19(8):47. doi: 10.1007/s11926-017-0677-1.
This review provides an update on the evolution of, manufacturing of, and regulations for biosimilars in Asian countries.
The use of biologics revolutionized the treatment of various diseases. However, the high cost of biologics remained unaffordable for most Asian patients and increases the financial burden of Asian governments. The development of biosimilars provides the best solution for this predicament. A great boom of biosimilars is developing in Asia. Hundreds of biopharmaceutical companies have established their manufacturing facilities and provide affordable products for Asian patients. Regulation guidelines and international harmonization are evolving. Better manufacturing quality and post-market pharmacovigilance are needed in Asia despite the rapid evolution of biosimilar development.
本综述介绍了亚洲国家生物类似药的发展、制造和监管的最新情况。
生物制剂的使用彻底改变了各种疾病的治疗方法。然而，生物制剂的高成本对大多数亚洲患者来说仍然难以负担，并增加了亚洲政府的财政负担。生物类似药的开发为此困境提供了最佳解决方案。亚洲的生物类似药正在蓬勃发展。数百家生物制药公司已经建立了自己的制造设施，为亚洲患者提供了负担得起的产品。监管指南和国际协调正在发展。尽管生物类似药的发展迅速，但亚洲仍需要更好的制造质量和上市后药物警戒。
