12-Year Biologics Exclusivity Almost Inevitable

The passage of the US Senate's healthcare reform bill and its reconciliation with the House bill will have a major bearing on the future of pharmaceutical market dynamics. One of the most hotly-debated issues in the bill is the introduction of a regulatory pathway to approve biosimilars (follow-on biologics) and market exclusivity for originator products. With both bills supporting a minimum 12-year period, BMI believes this outcome is almost inevitable, providing a blow for the Federal Trade Commission (FTC) and the Obama administration, which had backed shorter 5- and 7-year periods

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