Abstract: With the increasing maturity of regulatory law & policies and the gradual acceptance of biosimilars and biobetters by stakeholders, a clear and comprehensive understanding about the industry status & trend of biosimilars and biobetters is beneficial for biopharmaceutical companies to map out reasonable development strategy for investment and cooperation and thus promote their R&D of biologics and participation in the competition in regional or global market. In order to provide relevant organizations with effective decision-making support based on competitive intelligence for the strategy formulation and implementation of R&D, investment and cooperation in biopharmaceutical industry, this paper firstly made a clear definition and introduction of biosimilars and biobetters, then comparatively analyzed the industry status & trend of biosimilars and biobetters from the perspectives of R&D progress, competitive landscape, advantages & disadvantages, and risk & value in major countries or regional markets.