Biosimilar uptake has been low in the United States so far, with market shares for most biosimilars under 10%. Given the cost savings potential, trying to increase biosimilar uptake has been high on Congress’ agenda. There are many bills pending in Congress dealing with issues from a variety of angles, such as changes to the FDA Purple Book listing of biologic drugs, limits on patent litigation, changes to patent office proceedings, and ways to combat anticompetitive behavior, such as innovator product sponsors inappropriately withholding samples. But will they actually help bring biosimilars to market more quickly?
Using data compiled for BiologicsHQ.com, we analyzed 2 bills, the Affordable Prescriptions for Patients Act of 2019 (S.1416) and the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (HR.3991), that propose changes to patent litigation by limiting the number of patents a reference product sponsor can assert in a patent litigation to see how many biosimilar cases they would have impacted so far and whether they would really help bring biosimilars to market sooner.
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