Two executives—one from a leading generics manufacturer, the other from a leading brand manufacturer—argue the pros and cons of implementing an abbreviated US regulatory framework for the approval of biogeneric products.
The battle for enhanced savings in prescription medicine is about to take center stage in the arena of regulatory and political debate, and the winners could be US consumers. The stakes are high. Biopharmaceutical products currently have annual sales exceeding $30 billion and several of these products, which were developed during the 1980s, have lost, or will soon lose, patent protection. Sources estimate that within the next five years, biopharmaceutical products with annual sales in excess of $10 billion will lose patent protection. These products would be eligible for competition from generic biopharmaceuticals if an approval process existed. Below, executives from a leading generics manufacturer and a leading brand biologic manufacturer present arguments for and against the introduction of such a mechanism for biogeneric approval in the United States.
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Ben-Maimon, C., Garnick, R. Biogenerics at the crossroads. Nat Biotechnol 24, 268 (2006). https://doi.org/10.1038/nbt0306-268a
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DOI: https://doi.org/10.1038/nbt0306-268a
