Wen-Chan Tsai1. 1. School of Medicine Kaohsiung Medical University, Department of Internal Medicine, Kaohsiung Medical University Hospital, 100 Tzyou 1st Road, Kaohsiung, Taiwan. d10153@ms14.hinet.net.
Abstract
PURPOSE OF REVIEW: This review provides an update on the evolution of, manufacturing of, and regulations for biosimilars in Asian countries. RECENT FINDINGS: 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.
PURPOSE OF REVIEW: This review provides an update on the evolution of, manufacturing of, and regulations for biosimilars in Asian countries. RECENT FINDINGS: 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.
Authors: Moonyza A A Kamil; Nisha S Chandran; Sri Katon Sulistyaningrum; Murlidhar Rajagopalan; Sushil Tahiliani; Jennifer Hsiao; Haley Naik; Vivian Shi; John W Frew Journal: Int J Dermatol Date: 2020-05-20 Impact factor: 2.736
Authors: Edward Mezones-Holguin; Rocio Violeta Gamboa-Cardenas; Gadwyn Sanchez-Felix; José Chávez-Corrales; Luis Miguel Helguero-Santin; Luis Max Laban Seminario; Paula Alejandra Burela-Prado; Maribel Marilu Castro-Reyes; Fabian Fiestas Journal: Front Pharmacol Date: 2019-11-15 Impact factor: 5.810