News

News

Can Congress Speed Biosimilars to Market by Limiting Patent Litigations?

by Ha Kung Wong; April Breyer Menon
September 30, 2019

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.

Read the full article here.

    Methodology

    Information contained in the Venable 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 BiologicsHQ database.

    Disclaimer

    The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

    Subscribe for Future Updates

      captcha