OBJECTIVES: To assess the current biosimilar landscape across major Asia-Pac countries to determine points of convergence and divergence of regulatory requirements for interchangeability, substitution, and indication extrapolation relative to the reference product.

METHODS: This study employed a systematic review of biosimilar-relevant policies and regulations (in English and local languages), peer-reviewed publications, and local industry insights on biosimilar regulatory pathway in selected Asia-Pac markets. Statistical analyses were conducted on the number of currently-approved biosimilars, number of biosimilar guidelines, and average time to approval. In addition, interviews with practicing clinicians with biosimilar experience and payers were conducted.

RESULTS: Overall, biosimilar experiences were highly variable across the Asia-Pac countries. China, Korea, and Japan led the landscape in terms of regulatory maturity, based on the number and specificity of approval guidelines as well as on the number of marketed biosimilars. Taiwan and Malaysia were two “emerging” biosimilar countries with recent establishment of proprietary guidelines, leading to a subsequent increase in annual biosimilar approval rate. In addition, the degree of specificity around interchangeability of biosimilars for respective reference products and indication extrapolation was positively correlated with the number of biosimilars approved on the market as well as stakeholder perception of biosimilar utilisation.

Generally, there was high variability in interpretation of “interchangeability”, “substitution”, and “switching” across countries. As such, substitution occurred widely at physician level usually with bio-naïve patients, especially for products with demonstrated similarity and clinical profile. Indication extrapolation was also generally not allowed unless data for each claimed indication was provided – with the exception of Korea, where extrapolation was possible if the three requirements specified in the guideline were met.

CONCLUSIONS: Despite economic advantages of biosimilars, uniform adoption in Asia has yet to occur. Convergence of regulatory guidance across the region is expected to be an important driver of widespread biosimilar uptake in Asia-Pac.