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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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Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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