BPCIA Litigation Related to Proposed Eylea Biosimilar CT-P42 Filed

by April Breyer Menon | Nov 22, 2023 | Focus, News

On November 8, 2023, Regeneron Pharmaceuticals Inc. filed a BPCIA Complaint against Celltrion Inc. in the district court for the northern district of West Virginia, asking the Court to block CT-P42 – Celltrion’s proposed biosimilar of Regeneron’s drug...

First Biosimilar and Interchangeable of Stelara® (ustekinumab) Approved in the U.S.

by April Breyer Menon | Nov 5, 2023 | Focus, News

On October 31, 2023, the FDA approved Amgen’s Wezlana™ (ustekinumab-auub) as the first biosimilar and interchangeable of Johnson & Johnson / Janssen’s Stelara® (ustekinumab). In May 2023, Amgen and Janssen settled their BPCIA lawsuit, with an agreement...

Complimentary Life Sciences Webinar Series

by April Breyer Menon | Oct 6, 2023 | Focus, News

We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our seasoned attorneys across various practices who...

New FDA Guidance Removes Interchangeability Statement from Product Labels

by April Breyer Menon | Oct 5, 2023 | Focus, News

On September 18, 2023, the FDA issued a new draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products,” updating the previous labeling guidance “Labeling for Biosimilar Products” from July 2018. According to the FDA, the significant changes from...

First List of Drugs for Medicare Price Negotiations Published Includes Three Biologics

by April Breyer Menon | Sep 25, 2023 | Focus, News

The Inflation Reduction Act (IRA), signed into law on August 16, 2022, allows the federal government to negotiate prices for some high-cost drugs covered under Medicare. Under the law, many small molecule and biologic drugs that do not have approved and marketed...

PREVAIL Act Reforms at the PTAB

by April Breyer Menon | Aug 14, 2023 | Focus, News

The Act’s Objectives USPTO data indicate that as many as 80% of instituted Patent Trial and Appeal Board (PTAB) proceedings that reach a final written decision (FWD) result in the invalidation of at least one challenged patent claim, with 65% of those proceedings...

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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.

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