Patent protection and FDA exclusivities are the two principal forms of protection available to companies that develop therapeutic monoclonal antibodies. Propo-sed changes to both forms of protection are currently being debated in the United States Congress. Specifically, Congress is presently debating both biosimilar and patent reform legislations. Although no bill has yet passed, it is expected that patent reform legislation should pass this year. It is less likely that a biosimilar bill will pass this year. However, when legislations are enacted, the changes will significantly impact the business of therapeutic monoclonal antibodies.
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