PHP14 - Assessment of Biosimilar Landscape in Korea, Malaysia, Singapore and Taiwan

Abstract

Biosimilar has attracted tremendous interest and controversy in the past decade. Several mature healthcare markets in Asia Pacific has not only developed regulatory frameworks to approve biosimilar, but also taken initiatives to promote utilisation. This study aims to assess the current biosimilar landscape in Korea, Taiwan, Singapore and Malaysia and explore tactics to drive biosimilar adoption. Secondary research was conducted from January to March 2016 on all available information in the public domain. Biosimilar registration frameworks from Singapore, Korea, Taiwan and Malaysia were first retrieved from respective government sources. In a systematic analysis, each framework’s definition of biosimilar, references and pre/ post submission requirements were assessed. Other associated factors for biosimilars development and utilisation (e.g. government funding, joint-venture, etc.) were identified and evaluated through a second wave of desk research. In a final analysis, all regulatory variants as well as external influencing factors were compared qualitatively against the current the number of biosimilar approved to assess the most critical factor that drive biosimilar development and/or adoption. All in-scope countries have adopted their frameworks from the European Medicines Agency guidelines and were similar in nature. Although clinical trial requirements waiver (Taiwan) and abbreviated license pathway (Singapore) seem to make Taiwan and Singapore an attractive option, very few biosimilars are approved. Korea, on the other hand, is the forerunner in biosimilar development, with 12 biosimilars approved to date (including 5 monoclonal antibodies) given high public attention and government investment on biosimilar research & development cost, regulatory consulting service, marketing strategies and construction of good manufacturing practice facilities. Biosimilar environments are complex and dynamic and creation of biosimilar approval guidelines is insufficient to drive development of biosimilar industry. Strong public awareness and government support will be essential for other Asia markets, including Singapore, Taiwan and Malaysia to further strengthen their biosimilar industry.