12^th Asian Biologics and Biosimilars Congress

The global biosimilar market is growing rapidly as patents on blockbuster biologic drugs expire. Biologics are among the highest-cost treatments on the global market today, which implies the need for low-cost alternatives. In emerging markets, biosimilars already o er more a ordable prices, which are not only attractive, but indispensable to economies where expensive treatments are not  nancially feasible. Biosimilars have been approved in Europe for more than 10 years. While only recently launched in the United States, biosimilars have enormous potential to save money for the overall healthcare industry and patients. Selection of reference standard is the major challenge in biosimilar development. The country whose manufacturer target is required bridging studies between local and foreign versions of an originator biologic add significant cant costs to biosimilar development yet provide no patient has benefit or scientific rigor for the local approval of the biosimilar. Other challenges are the competitive landscape, frequent changes and uncertainty in approval processes at regulatory authorities, a current pricing system that reflects cost rather than value, the activities to be performed versus outsourced, high technology uncertainty over long time frames and the need for both signi cant complementary assets and substantial financing, naming issue, interchangeability and extrapolation of di erent indications. Regulations are still evolving globally hence meeting regulatory obligations and compliance is difficult in biosimilar development unless company adopts integrated strategic plan at the start of development having opinion from experts and stepwise input on regulatory and market to meet obligations. Strategies and path forward to success are: (1) Take position on fundamental regulatory issues and develop global strategy; (2) Optimizing global, regional and cross-functional collaboration; (3) Conduct in-depth pricing analysis and formulate regional strategy; (4) Develop patient education series/campaign. Patients must be educated so that they are willing to switch to a newer product that may not o er the same level of patient support; (5) Choose markets with limited or no access to innovator biologic; (6) Select country/region where regulatory agencies are willing to work with companies to bring biosimilar market to reduce healthcare cost; (7) Prioritize market entry based on changes in regulatory approval process and commercial viability. Based on scientific cally robust, simpli ed conditions, the selection of a comparator version of the originator for biosimilar development can be established which would be used as a global reference standard global biosimilar pipeline and market prospective are addressing production complexities through risk management and quality by design.