Update on Biosimilars in Asia.

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.