OBJECTIVES: Given financial constrain of health expenditure, the rising demand of biosimilar is driving pharmaceutical market globally. Because of the intricacy of biosimilar, various regulations, policies and pricing scheme are conducted between countries. The aim of this study was to review the development of biosimilar worldwide, and research on physicians’ perception of biosimilar in Taiwan.

METHODS: Secondary research through February 2018 was performed for data collection on regulations, policies and pricing scheme from various countries. Besides, an in-depth face-to-face physician interview was applied for perception survey. Total of 30 physicians experienced in practicing biologics from North (50%), Central (30%) and South (20%) of Taiwan were investigated. Descriptive analysis was conducted to address the differences of policies and physicians’ perception about biosimilar.

RESULTS: There was no significant discrepancy about regulatory approval requirements between countries, but substitution, interchangeability and pharmacovigilance. Most European countries already set up rules of substitutions and interchangeability of biosimilar at physician’s discretion. Among studied countries, biosimilar was priced at 70% ~ 90% of the originator. In Taiwan, relevant regulations were developed based on EMA guideline. There were only three products got regulatory and reimbursement approval by 2017. Based on the interview, around 80% of physicians had positive attitude in international pharmaceutical companies and 60% in international generic manufactures regarding the confidence of using biosimilar. The most important factor of impact level on prescribing biosimilar is clinical trial outcomes (93%) and followed by biosimilar developer company image (80%).

CONCLUSIONS: Biosimilar is one of alternatives to relieve health burden; most countries have put in place specific policies for promoting access to biosimilar. Enhancing awareness of biosimilar is needed; more information of efficacy and safety is must to build up physicians trust on biosimilar. Therefore, well-established policies for managing risks and benefits of biosimilar are expected in the future in Taiwan.