Global Biosimilar Financing Opportunity


CLIENT: Large manufacturer with significant global penetration looking to understand the threat that biosimilars pose to its biologic portfolio as well as opportunities for developing biosimilars for other products in emerging markets.
BUSINESS QUESTION: What is the current regulatory, access / reimbursement and competitive landscape for biosimilars within each of the BRICKMT markets, and which threats or opportunities should be considered within a 5 year outlook?
OUR APPROACH: ISA built upon existing market knowledge, triangulated and validated data sources, and synthesized information to critically assess risks and opportunities.

  • Regulatory
    • The ISA Team drew upon their extensive project experience and depth in each of the BRICKMT markets as well as performed a rigorous secondary research analysis to characterize the current state of biosimilar regulations in the BRICKMT markets
    • Discussions with ISA’s network of qualified and validated Key Stakeholders within each market indicated that the official guidelines did not necessarily match the reality of biosimilar readiness, and so additional key regulatory authorities were contacted in each market in order to validate the actual degree of implementation of these regulations
  • Access and Reimbursement
    • A thorough evaluation was conducted to determine the current level of access for a market basket of higher-cost biologics across national, sub-national, regional, provincial, hospital and private financing schemes
    • Each market was analyzed based on financing mechanisms, tender and procurement processes, substitution policies, regional and provincial financing ability, hospital and local budgets, and cost-sharing burdens to allow the prediction of future biosimilar financing opportunities
  • Synthesis
    • By combining the regulatory and market-specific evaluations, ISA was able to both forecast the future access of biosimilars and create a risk and opportunity rating for each market
RESULT: The client developed a biologic defense and biosimilar manufacturing plan over the next five years throughout these seven emerging markets based upon ISA’s analyses and recommendations.