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The international market potential for new biopharmaceuticals is expanding rapidly. However to be successful in these growing markets, manufacturers must develop effective strategies to address the exigencies of price regulation and government sponsored reimbursement schemes. Biopharmaceuticals face unique challenges. For these products, there are significant research and development costs and premium pricing is often required to offset the initial investment. Moreover, clinical trials for these products are typically designed to demonstrate safety and efficacy, but not superiority over existing agents. All countries are becoming increasingly interested in technology assessments and economic evaluations of pharmaceuticals and other medical interventions as they try to make difficult decisions on allocating funds. A lack of evidence demonstrating superiority is often cited by drug plan managers as the reason products are not included on drug plan formularies. |
